Data / Medical devices / United States / Boston Scientific Corporation

Boston Scientific Corporation: FDA-registered device maker in Saint Paul, MN, United States, 318 510(k) clearances and 47 PMA approvals

Name: Boston Scientific Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Boston Scientific Corporation is registered with the FDA (registration 2124215) in Saint Paul, MN, United States. It lists 167 device types. The FDA files 318 510(k) clearances and 47 PMA approvals under its listings, the newest dated September 11, 2026. 86 recall events name it as the recalling firm (9 Class I). Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Boston Scientific Corporation

FDA registration number: 2124215
Address: 4100 Hamline Ave N, Saint Paul, MN, United States, 55112
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
First device listed: September 9, 1983
Registered through: 2027
Brand names listed: 2x8 Contact Lead Extension Kit, 8 Contact Extension Kit, AC Power Cord, AC/DC Power Supply, ACCOLADE, ACCOLADE MRI, ACUITY STEERABLE, ACUITY Spiral and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Complaint file establishment	accessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Complaint file establishment	accessdata.fda.gov
Adaptor, Catheter	GCE	1	Specification developer	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Complaint file establishment	accessdata.fda.gov
Agent, Bulking, Injectable For Gastro-Urology Use	LNM	3	Complaint file establishment	accessdata.fda.gov
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	NOY	2	Complaint file establishment	accessdata.fda.gov
Agents, Embolic, For Treatment Of Uterine Fibroids	NAJ	2	Complaint file establishment	accessdata.fda.gov
Amplifier And Signal Conditioner, Transducer Signal	DRQ	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Analyzer, Pacemaker Generator Function	DTC	2	Specification developer	accessdata.fda.gov
Aspiration Thrombectomy Catheter	QEZ	2	Complaint file establishment	accessdata.fda.gov
Biopsy Needle	FCG	2	Complaint file establishment	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Complaint file establishment	accessdata.fda.gov
Cable, Electrode	IKD	2	Complaint file establishment	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Cardiac Ablation Percutaneous Catheter	LPB	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Cardiovascular Procedure Kit	OEZ	2	Complaint file establishment	accessdata.fda.gov
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Coronary, Atherectomy	MCX	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Intracardiac Mapping, High-Density Array	MTD	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Intravascular Occluding, Temporary	MJN	2	Complaint file establishment	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Complaint file establishment	accessdata.fda.gov
Catheter, Nephrostomy	LJE	U	Complaint file establishment	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Complaint file establishment	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	NWX	3	Complaint file establishment	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	OAD	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Percutaneous, Cutting/Scoring	PNO	2	Complaint file establishment	accessdata.fda.gov
Catheter, Peripheral, Atherectomy	MCW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Catheter, Peritoneal	GBW	1	Complaint file establishment	accessdata.fda.gov
Catheter, Septostomy	DXF	2	Complaint file establishment	accessdata.fda.gov
Catheter, Steerable	DRA	2	Manufacturer, Specification developer	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Complaint file establishment	accessdata.fda.gov
Catheter, Ureteral, Gastro-Urology	EYB	2	Complaint file establishment	accessdata.fda.gov
Catheter, Urethral	GBM	2	Complaint file establishment	accessdata.fda.gov
Catheter, Urological	KOD	2	Complaint file establishment	accessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, Percutaneous	LOX	2	Complaint file establishment	accessdata.fda.gov
Collagen Surgical Mesh Containing Drugs	PIJ	2	Complaint file establishment	accessdata.fda.gov
Computer, Blood-Pressure	DSK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Connector, Ureteral Catheter	EYK	1	Complaint file establishment	accessdata.fda.gov
Coronary Drug-Eluting Stent	NIQ	3	Complaint file establishment	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Complaint file establishment	accessdata.fda.gov
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	NIK	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Device, Impotence, Mechanical/Hydraulic	FHW	3	Manufacturer	accessdata.fda.gov
Device, Incontinence, Mechanical/Hydraulic	EZY	3	Complaint file establishment, Manufacturer	accessdata.fda.gov
Device, Neurovascular Embolization	HCG	2	Complaint file establishment	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Complaint file establishment	accessdata.fda.gov
Dilator, Catheter	GCC	1	Complaint file establishment	accessdata.fda.gov
Dilator, Catheter, Ureteral	EZN	2	Complaint file establishment	accessdata.fda.gov
Dilator, Esophageal	KNQ	2	Complaint file establishment	accessdata.fda.gov
Dilator, Urethral	KOE	2	Complaint file establishment	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Complaint file establishment	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Complaint file establishment	accessdata.fda.gov
Dislodger, Stone, Flexible	FGO	2	Complaint file establishment	accessdata.fda.gov
Dressing, Compression	MHW	1	Complaint file establishment	accessdata.fda.gov
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	OJX	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	NVN	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	OOB	3	Complaint file establishment	accessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty Catheter	ONU	3	Complaint file establishment	accessdata.fda.gov
Echocardiograph	DXK	2	Complaint file establishment	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Complaint file establishment	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Complaint file establishment	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Complaint file establishment	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Complaint file establishment	accessdata.fda.gov
Evacuator, Bladder, Manually Operated	FFD	1	Complaint file establishment	accessdata.fda.gov
Evacuator, Gastro-Urology	KQT	2	Complaint file establishment	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Complaint file establishment	accessdata.fda.gov
Generator, Lesion, Radiofrequency	GXD	2	Manufacturer	accessdata.fda.gov
Gynecological Laparoscopic Kit	OHD	2	Complaint file establishment	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Complaint file establishment	accessdata.fda.gov
Hydrogel Spacer	OVB	2	Complaint file establishment	accessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)	LWS	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Implantable Pacemaker Pulse-Generator	DXY	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)	LWP	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	QON	3	Complaint file establishment	accessdata.fda.gov
Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories	QGD	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, General Obstetric-Gynecologic	KOH	1	Complaint file establishment	accessdata.fda.gov
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	PWJ	2	Complaint file establishment	accessdata.fda.gov
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse	PWI	2	Complaint file establishment	accessdata.fda.gov
Insufflator, Hysteroscopic	HIG	2	Complaint file establishment	accessdata.fda.gov
Intracranial Neurovascular Stent	NJE	f	Complaint file establishment	accessdata.fda.gov
Introducer, Catheter	DYB	2	Complaint file establishment	accessdata.fda.gov
Kit, Nephroscope	FGA	2	Complaint file establishment	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Complaint file establishment	accessdata.fda.gov
Lithotriptor, Electro-Hydraulic	FFK	2	Complaint file establishment	accessdata.fda.gov
Mechanical Thrombolysis Catheter	QEY	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical	FTM	2	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical, For Stress Urinary Incontinence, Male	OTM	2	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	OTO	2	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	PAH	2	Complaint file establishment	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	OTN	2	Complaint file establishment	accessdata.fda.gov
Microspheres Radionuclide	NAW	3	Complaint file establishment	accessdata.fda.gov
Needle, Catheter	GCB	1	Complaint file establishment	accessdata.fda.gov
Non-Coring (Huber) Needle	PTI	2	Complaint file establishment	accessdata.fda.gov
Pacemaker Lead Adaptor	DTD	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted Components	OSR	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Penile Implant Surgical Accessories	QGA	1	Manufacturer	accessdata.fda.gov
Percutaneous Atrial Catheter Kit	OFK	2	Complaint file establishment	accessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	QZI	3	Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer	accessdata.fda.gov
Percutaneous Catheter, Ultrasound	PPN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Complaint file establishment	accessdata.fda.gov
Permanent Defibrillator Electrodes	NVY	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Permanent Pacemaker Electrode	DTB	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Manufacturer, Manufacturer for export	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Manufacturer	accessdata.fda.gov
Programmer, Pacemaker	KRG	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Prosthesis, Penile	FAE	2	Complaint file establishment	accessdata.fda.gov
Prosthesis, Penis, Inflatable	JCW	3	Manufacturer	accessdata.fda.gov
Prosthesis, Tracheal, Expandable	JCT	2	Complaint file establishment	accessdata.fda.gov
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	NKE	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Pulse Generator, Permanent, Implantable	NVZ	3	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Pump, Infusion, Implanted, Programmable	LKK	3	Complaint file establishment	accessdata.fda.gov
Radiographic Protective Glove	IWP	1	Complaint file establishment	accessdata.fda.gov
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	MXD	2	Manufacturer, Specification developer	accessdata.fda.gov
Shield, Protective, Personnel	KPY	1	Complaint file establishment	accessdata.fda.gov
Shunt, Portosystemic, Endoprosthesis	MIR	3	Complaint file establishment	accessdata.fda.gov
Stand, Infusion	FOX	1	Complaint file establishment	accessdata.fda.gov
Stent, Carotid	NIM	3	Complaint file establishment	accessdata.fda.gov
Stent, Central Venous	QKJ	3	Complaint file establishment	accessdata.fda.gov
Stent, Coronary	MAF	3	Complaint file establishment	accessdata.fda.gov
Stent, Iliac	NIO	3	Complaint file establishment	accessdata.fda.gov
Stent, Iliac Vein	QAN	3	Complaint file establishment	accessdata.fda.gov
Stent, Renal	NIN	3	Complaint file establishment	accessdata.fda.gov
Stent, Superficial Femoral Artery	NIP	3	Complaint file establishment	accessdata.fda.gov
Stent, Superficial Femoral Artery, Drug-Eluting	NIU	3	Complaint file establishment	accessdata.fda.gov
Stent, Ureteral	FAD	2	Complaint file establishment	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Electrical, Implantable, For Incontinence	EZW	3	Complaint file establishment	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential Tremor	PJS	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	NHL	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian Tremor	MHY	3	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Implanted (Pain Relief)	GZB	2	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	LGW	3	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	QRB	3	Manufacturer	accessdata.fda.gov
Stylet For Catheter, Gastro-Urology	EZB	1	Complaint file establishment	accessdata.fda.gov
Stylet, Catheter	DRB	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	OCL	2	Complaint file establishment	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Complaint file establishment	accessdata.fda.gov
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	2	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Complaint file establishment	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Complaint file establishment	accessdata.fda.gov
System, Appendage Closure, Left Atrial	NGV	3	Complaint file establishment	accessdata.fda.gov
System, Applicator, Radionuclide, Manual	IWJ	1	Complaint file establishment	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Temporary Carotid Catheter For Embolic Capture	NTE	2	Complaint file establishment	accessdata.fda.gov
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	PUM	2	Complaint file establishment	accessdata.fda.gov
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection	NFA	2	Complaint file establishment	accessdata.fda.gov
Transducer, Pressure, Catheter Tip	DXO	2	Complaint file establishment	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Manufacturer	accessdata.fda.gov
Tube, Drainage, Suprapubic	FFA	2	Complaint file establishment	accessdata.fda.gov
Unit, Cryosurgical, Accessories	GEH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Complaint file establishment, Manufacturer, Manufacturer for export	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Wire, Guide, Catheter, Exempt	PTL	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 318.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 11, 2026	K262151	SpaceOAR Flex System	OVB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 3, 2026	K262460	Rezum System	KNS	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
August 26, 2026	K261153	LithoVue Elite Digital Flexible Ureteroscope System	FGB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 24, 2026	K260246	SEISMIQ Intravascular Lithotripsy System	PPN	Substantially Equivalent	Bolt Medical, Inc.	accessdata.fda.gov
August 21, 2026	K253692	AVVIGO+ Multi-Modality Guidance System	DQK	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
August 12, 2026	K262406	EluPro Antibiotic-Eluting BioEnvelope	FTM	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
August 4, 2026	K261915	Navigator Flex Ureteral Access Sheath Set	FED	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 24, 2026	K262462	TheraSphere 360 Y-90 Management Platform	LLZ	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 18, 2026	K260100	MOSES Raydar	GEX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 15, 2026	K260771	TruSelect 2.6 Microcatheter	KRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 23, 2026	K261012	OptiMap Catheter - 60mm (OPTI-CATH2-60)	MTD	Substantially Equivalent	Cortex, Inc.	accessdata.fda.gov
April 8, 2026	K260816	OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)	OBJ	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
March 27, 2026	K251273	Asurys Fluid Management System	HIG	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 13, 2026	K253205	OptiMap Catheter - 50mm (OPTI-CATH2-50)	MTD	Substantially Equivalent	Cortex, Inc.	accessdata.fda.gov
February 10, 2026	K260119	SpaceOAR Vue System (SV-2101)	OVB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 30, 2025	K252529	Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0068130120)	GEX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 24, 2025	K252703	LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)	FGB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 12, 2025	K252593	LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)	MXD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 7, 2025	K251247	GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)	GXD	Substantially Equivalent	Boston Scientific Neuromodulation Corporation	accessdata.fda.gov
July 9, 2025	K251759	Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers	GEX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 27, 2025	K250310	VIKING Fixed Curve Diagnostic Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 11, 2025	K250584	Rezum System	KNS	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 28, 2025	K251344	OptiMap System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 15, 2025	K250824	Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set	FAD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 25, 2025	K250225	Bolt Intravascular Lithotripsy (IVL) System	PPN	Substantially Equivalent	Bolt Medical, Inc.	accessdata.fda.gov
March 21, 2025	K250517	Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006	FED	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 20, 2025	K250468	iSLEEVE Introducer Set	DYB	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
November 1, 2024	K242076	VersaCross RF Wire	DXF	Substantially Equivalent	Baylis Medical Company	accessdata.fda.gov
November 1, 2024	K240366	EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 18, 2024	K243245	IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)	GEH	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
October 3, 2024	K242507	OBSIDIO Conformable Embolic	KRD	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
August 29, 2024	K241227	RHYTHMIA HDx Mapping System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 12, 2024	K241720	VersaCross Connect Transseptal Dilator	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
July 10, 2024	K241683	Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314	LIT	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 1, 2024	K241598	LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500)	FGB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 29, 2024	K241207	SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02)	QEW	Substantially Equivalent	Devoro Medical, Inc.	accessdata.fda.gov
March 13, 2024	K234002	ICEfx Cryoablation System (FPRCH8000-02)	GEH	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
February 1, 2024	K240018	WATCHMAN TruSteer Access System (M635TU90050)	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 20, 2023	K231227	SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
December 14, 2023	K233647	VersaCross Connect Transseptal Dilator	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
December 12, 2023	K233645	StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection	FGB	Substantially Equivalent	Boston Scientific Corporation -	accessdata.fda.gov
December 11, 2023	K233248	FARADRIVE Steerable Sheath	DRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 30, 2023	K233503	14F iSLEEVE Introducer Set	DYB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 22, 2023	K232635	IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)	GEH	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
October 27, 2023	K233207	Polaris X Unidirectional Steerable Diagnostic Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 29, 2023	K232651	BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 26, 2023	K230884	AVVIGO'+ Multi-Modality Guidance System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 19, 2023	K231328	LUX-Dx II (M302); LUX-Dx II+ (M312)	MXD	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
August 8, 2023	K230551	Visual-ICE Cryoablation System	GEH	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 8, 2023	K223633	Rubicon Control Support Catheter (H749394323506A1)	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 29, 2023	K231549	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System	OTN	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 27, 2023	K230706	EMBOLD Soft Detachable Coil System	KRD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 25, 2023	K231176	Stingray LP Catheter	DQY	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
April 25, 2023	K230503	Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable	DRF	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
April 11, 2023	K230402	ENROUTE® Transcarotid Neuroprotection System	NTE	Substantially Equivalent	Silk Road Medical	accessdata.fda.gov
March 22, 2023	K223824	POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor	DRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 17, 2023	K223666	Ablacath Mapping Catheter	MTD	Substantially Equivalent	Ablacon, Inc.	accessdata.fda.gov
December 19, 2022	K221351	Mechanical Guidewire	DQX	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
September 23, 2022	K222568	OptiCross 18 Peripheral Imaging Catheter	OBJ	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 6, 2022	K220962	ROTAPRO Rotational Atherectomy System	MCW	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 2, 2022	K221414	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	LIT	Substantially Equivalent	Silk Road Medical, Inc.	accessdata.fda.gov
June 30, 2022	K213582	Epicardial Access System	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
June 10, 2022	K220796	IntellaMap Orion High Resolution Mapping Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 9, 2022	K220414	VersaCross Connect Transseptal Dilator	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
April 20, 2022	K220866	EKOS+ Endovascular Device	QEY	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
April 12, 2022	K213398	EMBOLD Fibered Detachable Coil System	KRD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 24, 2022	K220629	Emerge Monorail PTCA Dilatation Catheter	LOX	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
March 16, 2022	K213823	Intera Refill Kit	PTI	Substantially Equivalent	Intera Oncology, Inc.	accessdata.fda.gov
December 20, 2021	K211847	AdVance XP Male Sling System	OTM	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 14, 2021	K213422	EkoSonic Endovascular Device, EKOS+ Endovascular Device	QEY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 20, 2021	K212490	AVVIGO Guidance System II	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 14, 2021	K211121	Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit	PTI	Substantially Equivalent	Intera Oncology, Inc.	accessdata.fda.gov
August 13, 2021	K212228	WATCHMAN FXD Curve Access System	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 25, 2021	K210889	iLab Polaris Multi-Modality Guidance System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 25, 2021	K210608	LUX-Dx Insertable Cardiac Monitor	MXD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 20, 2021	K203276	Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)	NOY	Substantially Equivalent	Biocompatibles UK Ltd (Part of Boston Scientific Corporation	accessdata.fda.gov
December 24, 2020	K203544	UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories	GEX	Substantially Equivalent	Lumenis, Ltd.	accessdata.fda.gov
October 2, 2020	K202218	ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device	QEW	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 15, 2020	K201170	Athletis PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 28, 2020	K202224	SpaceOAR System	OVB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 28, 2020	K201792	TRUSELECT Microcatheter	KRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 23, 2020	K201713	AVVIGO Guidance System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 26, 2020	K193473	LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US	MXD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 15, 2020	K201313	CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)	FTM	Substantially Equivalent	Aziyo Biologics, Inc.	accessdata.fda.gov
June 12, 2020	K201288	ExpanSure Large Access Transseptal Dilator	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
May 29, 2020	K201178	iLab Polaris Multi-Modality Guidance System	DQK	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
April 17, 2020	K200733	Opticross 35 15 MHz Peripheral Imaging Catheter	ITX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
February 19, 2020	K192460	Sentinel Cerebral Protection System	PUM	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
January 2, 2020	K191446	Ureteral Stent Systems, Biliary Drainage Catheters	FAD	Unknown	Boston Scientific Corporation	accessdata.fda.gov
December 23, 2019	K193279	Comet II Pressure Guidewire	DXO	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 27, 2019	K192438	Rhythmia HDxTM Mapping System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 19, 2019	K182971	SpaceOAR Vue Hydrogel	OVB	Substantially Equivalent	Augmenix, Inc.	accessdata.fda.gov
July 2, 2019	K191008	iLab Polaris Multi-Modality Guidance System	DQK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 7, 2019	K183649	Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable	DRF	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
June 7, 2019	K183632	Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable	DRF	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
May 20, 2019	K183655	VersaCross Transseptal Sheath	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
April 17, 2019	K190688	VersaCross Steerable Sheath, VersaCross Transseptal Dilator	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
April 16, 2019	K183619	Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device	FAE	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 5, 2019	K183361	EkoSonic Endovascular Device with Control Unit 4.0	QEY	Substantially Equivalent	Btg International, Inc.	accessdata.fda.gov
March 21, 2019	K182064	ExpanSure Transseptal Dilation System	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
March 10, 2026	P130030	REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE	MAF	75	March 10, 2026	accessdata.fda.gov
February 29, 2024	P230035	AGENT Paclitaxel-Coated Balloon Catheter	OOB	8	August 28, 2026	accessdata.fda.gov
January 30, 2024	P230030	FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable,	QZI	24	October 2, 2026	accessdata.fda.gov
August 8, 2023	P220032	POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories	OAE	12	May 29, 2026	accessdata.fda.gov
March 17, 2021	P200029	TheraSphere	NAW	14	October 13, 2026	accessdata.fda.gov
October 30, 2020	P190019	Ranger Paclitaxel-Coated PTA Balloon Catheter	ONU	41	August 4, 2026	accessdata.fda.gov
January 28, 2020	P170023	Bulkamid Urethral Bulking System	LNM	21	July 1, 2026	accessdata.fda.gov
November 13, 2019	P180046	Axonics Sacral Neuromodulation System	EZW	103	August 7, 2026	accessdata.fda.gov
September 6, 2019	P190006	Axonics Sacral Neuromodulation System	QON	103	August 7, 2026	accessdata.fda.gov
September 18, 2018	P180011	Eluvia Drug-Eluting Vascular Stent System	NIU	67	August 21, 2026	accessdata.fda.gov
December 8, 2017	P150031	VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM	NHL	94	October 15, 2026	accessdata.fda.gov
April 25, 2016	P150012	IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD	LWP	186	October 3, 2026	accessdata.fda.gov
February 24, 2016	P150005	BLAZER OPEN-IRRIGATED ABLATION CATHETER	OAD	91	December 5, 2025	accessdata.fda.gov
October 2, 2015	P150003	SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM	NIQ	109	August 21, 2026	accessdata.fda.gov
July 21, 2015	P140028	INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM	NIP	86	August 21, 2026	accessdata.fda.gov
May 18, 2015	P140026	ENROUTE TRANSCAROTID STENT SYSTEM	NIM	31	January 8, 2026	accessdata.fda.gov
March 13, 2015	P130013	WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY	NGV	84	August 28, 2026	accessdata.fda.gov
September 28, 2012	P110042	SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM	LWS	208	October 2, 2026	accessdata.fda.gov
April 13, 2012	P110035	EPIC SELF-EXPANDING NITINOL STENT SYSTEM	NIO	76	August 21, 2026	accessdata.fda.gov
November 22, 2011	P110010	PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM	NIQ	207	January 14, 2025	accessdata.fda.gov
March 5, 2010	P090003	EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM	NIO	53	May 6, 2026	accessdata.fda.gov
December 11, 2008	P060006	BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM	NIN	104	December 12, 2023	accessdata.fda.gov
October 23, 2008	P050019	CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS	NIM	41	September 19, 2025	accessdata.fda.gov
April 13, 2007	P050046	ACUITY STEERABLE LEAD SYSTEM	OJX	29	September 24, 2021	accessdata.fda.gov
April 27, 2004	P030017	PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM	LGW	373	September 22, 2026	accessdata.fda.gov
January 26, 2004	P030005	CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE	NKE	244	October 3, 2026	accessdata.fda.gov
August 25, 2003	P020025	EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM	OAD	141	October 17, 2025	accessdata.fda.gov
May 2, 2002	P010012	CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL	NIK	580	August 25, 2026	accessdata.fda.gov
November 16, 2001	P980033	WALLSTENT ENDOPROSTHESIS	QKJ	65	May 6, 2026	accessdata.fda.gov
June 14, 2001	P000053	AMS SPHINCTER 800 URINARY CONTROL SYSTEM	EZY	135	September 14, 2026	accessdata.fda.gov
April 18, 2000	P950020	FLEXATOME CUTTING BALLOON	NWX	139	January 27, 2026	accessdata.fda.gov
June 3, 1999	N970003	PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE	LWP	160	October 3, 2026	accessdata.fda.gov
March 12, 1999	P980037	ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER	MCX	93	August 1, 2025	accessdata.fda.gov
November 2, 1998	N970012	AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESES	JCW	131	September 14, 2026	accessdata.fda.gov
October 2, 1998	P960006	SWEET TIP(R) RX STEROID ELUTING LEAD	NVN	52	May 15, 2026	accessdata.fda.gov
July 18, 1997	P960040	VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM	LWS	485	August 25, 2026	accessdata.fda.gov
November 12, 1996	P960004	THINLINE ENDOCARDIAL PACING LEADS	NVN	105	June 3, 2026	accessdata.fda.gov
May 28, 1996	P940019	WALLSTENT(R) ILIAC ENDOPROSTHESIS	NIO	63	May 6, 2026	accessdata.fda.gov
March 11, 1996	P890055	MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM	LKK	86	March 16, 2026	accessdata.fda.gov
September 29, 1995	P930031	WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM	MIR	72	June 27, 2024	accessdata.fda.gov
March 10, 1995	P930035	VENTAK(R) P2 SYSTEM	LWS	36	May 15, 2026	accessdata.fda.gov
October 28, 1994	P920047	EPT-1000 CARDIAC ABLATION SYSTEM	LPB	133	October 17, 2025	accessdata.fda.gov
June 17, 1994	P910077	VENTAK(R) PRX (TM) MODEL 1700,1705 PULSE GENERATOR	LWS	184	July 1, 2026	accessdata.fda.gov
August 26, 1993	P910073	ENDOTAK LEAD SYSTEM	LWS	179	September 17, 2026	accessdata.fda.gov
May 28, 1993	P900056	ROTABLATOR(R)	MCX	219	October 21, 2026	accessdata.fda.gov
November 28, 1986	P860019	SCIMED PTCA DILATATION CATHETER	LOX	247	March 31, 2011	accessdata.fda.gov
October 4, 1985	P830060	VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS	LWS	85	May 15, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 6, 2026	99524	Class II	Ongoing	LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)	There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Delayed notification of an AF Burden Alert may delay clinical evaluation or therapeutic intervention of an atrial arrhythmia.	accessdata.fda.gov
June 11, 2026	99252	Class II	Ongoing	FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01	Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator st	accessdata.fda.gov
June 11, 2026	99251	Class II	Ongoing	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter	Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.	accessdata.fda.gov
June 11, 2026	99230	Class II	Ongoing	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter	Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.	accessdata.fda.gov
March 30, 2026	98679	Class II	Ongoing	LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5	For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the	accessdata.fda.gov
March 19, 2026	98615	Class I	Ongoing	Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO	Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the follo	accessdata.fda.gov
August 20, 2025	97467	Class I	Ongoing	ACCOLADE SR SL (Model L300)	Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUD	accessdata.fda.gov
July 24, 2025	97318	Class I	Ongoing	ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0	Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.	accessdata.fda.gov
June 25, 2025	97207	Class II	Ongoing	FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401	The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.	accessdata.fda.gov
June 10, 2025	97036	Class II	Ongoing	VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DE	Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.	accessdata.fda.gov
December 12, 2024	95969	Class I	Ongoing	ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)	A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.	accessdata.fda.gov
October 10, 2024	95514	Class I	Ongoing	Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.	Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.	accessdata.fda.gov
September 6, 2024	95441	Class II	Ongoing	Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.	Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.	accessdata.fda.gov
February 12, 2024	94082	Class I	Ongoing	Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050	Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).	accessdata.fda.gov
November 30, 2023	93519	Class II	Ongoing	Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA	The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.	accessdata.fda.gov
July 11, 2023	92760	Class II	Ongoing	EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator	There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.	accessdata.fda.gov
February 2, 2023	91646	Class II	Ongoing	LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.	Under specific circumstances, the U.S. product registration system did not send up enablement requests to U.S. LATITUDE Customer Support during an 8-month interval in 2022. For these patients, the HeartLogic Index and any associated Yellow Alerts are currently not visible in LATITUDE as may have been intended by the healthcare provider..	accessdata.fda.gov
September 30, 2022	90985	Class II	Ongoing	EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.	There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.	accessdata.fda.gov
July 7, 2022	90524	Class II	Ongoing	The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communicat	There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.	accessdata.fda.gov
June 3, 2021	88107	Class I	Ongoing	ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)	The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary hi	accessdata.fda.gov
June 3, 2021	88087	Class II	Ongoing	Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131	Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.	accessdata.fda.gov
December 15, 2020	87033	Class II	Terminated	ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.	Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure.	accessdata.fda.gov
December 2, 2020	86902	Class I	Terminated	EMBLEM S-ICD Model A209	Electrical overstress may lead to device malfunction.	accessdata.fda.gov
December 2, 2020	86866	Class II	Ongoing	EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209	Accelerated battery depletion may result in a need for device replacement earlier than expected.	accessdata.fda.gov
November 13, 2020	87014	Class I	Terminated	EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)	There is potential for fractures which results in the inability to delivery therapy.	accessdata.fda.gov
September 22, 2020	86534	Class II	Terminated	Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Application	There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.	accessdata.fda.gov
February 12, 2020	85077	Class II	Terminated	Boston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific	Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.	accessdata.fda.gov
August 21, 2019	83558	Class II	Ongoing	Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEMTM S-ICD Pulse Generator	Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.	accessdata.fda.gov
November 1, 2018	81471	Class II	Terminated	The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventric	Experienced accelerated battery depletion and a shortened replacement interval due to latent internal battery malfunctions.	accessdata.fda.gov
September 10, 2018	81006	Class II	Terminated	Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable sys	There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation.	accessdata.fda.gov
September 10, 2018	81001	Class II	Terminated	ESSENTIO Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.	accessdata.fda.gov
December 7, 2017	78787	Class II	Ongoing	ACCOLADE SR Pacemaker	Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).	accessdata.fda.gov
October 4, 2017	78323	Class II	Terminated	RESONATE EL ICD VR, Model D432, Sterile.	The devices have an incorrect firmware configuration.	accessdata.fda.gov
June 29, 2017	77803	Class II	Terminated	EMBLEM S-ICD, Model A209, Subcutaneous Implantable Cardioverter Defibrillator, RX. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrh	The device can deliver an atypical amount of energy due to memory corruption inside the device.	accessdata.fda.gov
January 12, 2017	76323	Class II	Terminated	Boston Scientific, EMBLEM S-ICD Programmer Model 3200 Programmer.	There is a potential for radio frequency (RF) interference to alter wireless communication from a programmer, which in rare instances may cause an S-ICD to perform an unintended command. This behavior can only occur during an active, in-clinic interrogation/programming session with the Model 3200 S-ICD programmer. There is no risk of this behavior occurring	accessdata.fda.gov
November 30, 2016	75813	Class II	Terminated	Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.	Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.	accessdata.fda.gov
June 15, 2016	74812	Class II	Terminated	Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.	Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval yet.	accessdata.fda.gov
December 10, 2015	72855	Class II	Terminated	Boston Scientific, MRI PROPONENT" SR, REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary	The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.	accessdata.fda.gov
November 25, 2015	72739	Class II	Terminated	Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed	Potential for separation of the proximal handle from the shaft.	accessdata.fda.gov
September 17, 2015	72225	Class II	Terminated	Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). Intended to provide defibrillation therapy.	Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communication mode. While this does not impact therapy delivery of device; this can impact likelihood of successfully establishing telemetry during first scan of device when using a single-channel programmer. Telemetry can be established with additional scans; once esta	accessdata.fda.gov
September 17, 2014	69291	Class II	Terminated	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Produc	Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to compromised performance of a low voltage (LV) capacitor. Boston Scientific updated their August 2013 Physician communication to include additional devices that may experience premature battery depletion due	accessdata.fda.gov
June 19, 2014	68700	Class II	Terminated	Boston Scientific ENDOTAK RELIANCE SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillati	A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices.	accessdata.fda.gov
August 29, 2013	66171	Class II	Terminated	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston	The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.	accessdata.fda.gov
July 15, 2013	65798	Class II	Terminated	Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.	Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge tim	accessdata.fda.gov
April 10, 2013	65096	Class II	Terminated	LATITUDE Patient Management System, Model 6488, Version 7.3. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a c	Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488 Version 7.3 because between March 4 and 27, 2013, a Siebel release caused ~5000 distributed PMR clinic faxes to display with illegible characters and not the required, Patient non-compliance information that was intended.	accessdata.fda.gov
March 1, 2013	64546	Class II	Terminated	Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.	An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.	accessdata.fda.gov
February 24, 2012	61390	Not yet classified	Terminated	Boston Scientific LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, Made in Malaysia. The LATITUDE Patient Management syste	Boston Scientific LATITUDE Patient Management System Communicators were shipped to the incorrect patients.	accessdata.fda.gov
January 19, 2012	61107	Not yet classified	Terminated	Boston Scientific, LATITUDE Patient Management System Communicator, Models 6476. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse gen	One (1) Model 6476 LATITUDE Communicator is unable to interrogate the patient's pulse generator. Boston Scientific has determined that this is due to a patient receiving an incorrect communicator. Therefore the communicator did not find and was unable to interrogate the assigned patients PG. Additionally when the patient attempted to set-up this incorrect co	accessdata.fda.gov
December 19, 2011	60945	Not yet classified	Terminated	LATITUDE Patient management System, Model 6488, software version 7.2. It is indicated for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.	Boston Scientific is conducting a recall involving the LATITUDE Patient Management System - Model 6488, software version 7.2 because patients are not able to perform setup. There is no risk to health associated with this issue.	accessdata.fda.gov
October 12, 2011	60244	Not yet classified	Terminated	LATITUDE Patient Management System, Models 6441, 6442, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Applica	Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a Red Alert within LAT	accessdata.fda.gov
August 12, 2011	59898	Not yet classified	Terminated	LATITUDE Paceart Integration Software, version 1.00 Model 6472. LATITUDE Paceart Integration is software and therefore does not have any serial numbers. However, the software version affected is version 1.00 and is distr	Boston Scientific has determined that under certain conditions, LATITUDE Paceart Integration (LPI) software may not properly transfer data resulting in the incorrect summary of programmed parameter values in the ICD Summary tab display and Current Programming Tachy summary section of the Paceart report.	accessdata.fda.gov
August 1, 2011	59686	Not yet classified	Terminated	Boston Scientific, LATITUDE Patient Management System Communicator, Model 6476, Distributed by Boston Scientific, 4100 Hamline Avenue North, St Paul, MN 55112-5798 Boston Scientific, LATITUDE RF Communicator & Software,	A limited number of Model 6476, 6482, and 6468 (Not available in the US) LATITUDE Communicators are unable to authenticate, and thus cannot connect to the LATITUDE System. Customers are instead receiving Latitude Temporarily Unavailable (LTU) message.	accessdata.fda.gov
May 25, 2011	59421	Not yet classified	Terminated	LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a c	Boston Scientific has identified two occurrences where the LATITUDE system did not process a data payload, which is the information uploaded to the LATITUDE system from a remote interrogation of the implanted device. These occurrences resulted in non-displayed payloads because the data is not posted to the website. If the payload is not displayed, the pertin	accessdata.fda.gov
January 10, 2011	57744	Not yet classified	Terminated	Boston Scientific's LATITUDE Patient Management System: LATITUDE 6.1 Patient Management System Website Server software, Model 6488 for United States Server software, Model 6465 for European Union LATITUDE 6.2 Patient Man	Boston Scientific has determined that data within certain printed reports obtained from the LATITUDE Patient Management System may not be accurate, in that, the Most Recent Presenting Electrogram (MRP-EGM) for some of the selected patients may be either missing or incorrect.	accessdata.fda.gov
July 22, 2010	56630	Not yet classified	Terminated	Guidant, CONTAK RENEWAL 3/3RF Models H170, H175, H177, H179, H210, H215, H217, H219, Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 CONTAK RENEWAL 4/4RF Models H190, H195, H197, H199, M170*,	Exposure to a magnet (typically in a clinic/hospital environment) may cause a magnetic reed switch to become permanently stuck in a closed position in certain Boston Scientific CRT-Ds and ICDs (CONTAK RENEWAL 3 / 3 RF / 4 / 4 RF and VITALITY HE implantable defibrillators). This prevents delivery of programmed tachy therapy, and use of the Patient Triggered M	accessdata.fda.gov
March 15, 2010	55216	Not yet classified	Terminated	Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, Models E102 and E110. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The product is indicated fo	Boston Scientific Corporation has stopped shipment and is retrieving unimplanted devices from US hospital shelves of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) after determining that some manufacturing process changes were not submitted for approval to the US Food & Drug Administration	accessdata.fda.gov
December 1, 2009	53994	Not yet classified	Terminated	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized using ethylene oxide.	BSC CRM provided important patient management information regarding Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs. Engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient mechanical stress to weaken the bond between the header and case when positioned subpectorally. A weakened header bond may alter	accessdata.fda.gov
September 10, 2009	53322	Not yet classified	Terminated	Boston Scientific, LATITUDE Communicator, Distributed by Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112. Models 6476 (USA) and 6468 (OUS)	Boston Scientific has determined that alert conditions for a limited subset of out-of-range Daily Measurements related to leads may not be recognized by Model 6476 (United States) or Model 6468 (Europe) LATITUDE in-home communicators. If a communicator fails to recognize a valid alert situation, notification for this or subsequent alerts for the same test wi	accessdata.fda.gov
August 7, 2009	53083	Not yet classified	Terminated	Guidant LATITUDE Communicator, model 6481, Boston Scientific 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. The LATITUDE Patient Management system enables physicians to periodically monitor both patient and devi	The L ATITUDE communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor afer initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in	accessdata.fda.gov
July 20, 2009	52809	Not yet classified	Terminated	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, Models N118 and N119. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 66112-5798, USA. The prod	Boston Scientific Cardiac Rhythm Management retrieved devices that could be subject to a potential for acute non-secure lead connections when implanted. Nonsecure lead connections can manifest as high impedance, or lead electrogram artifacts resulting in oversensing and/or inappropriate delivery of therapy.	accessdata.fda.gov
March 23, 2009	51713	Not yet classified	Terminated	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107.	Lead connection issues or fracture increases probability of inappropriate therapy: Inappropriate shocks, inappropriate anti-tachycardia pacing therapy, or inappropriate inhibition of needed bradycardia pacing therapy.	accessdata.fda.gov
March 4, 2009	51345	Not yet classified	Terminated	Guidant Contak Renewal 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF M177; 4AVT HE CRT-D R	In April 2007, Boston Scientific CRM communicated with physicians regarding the potential for reduced Elective Replacement Indicator (ERI) to Battery End of Life (EOL) time in a subset of implantable defibrillators due to degradation of a low-voltage capacitor. Since that time, the April 2007 advisory population has not experienced any clinically significant	accessdata.fda.gov
January 7, 2008	46297	Not yet classified	Terminated	VITALITY DR+ Implantable Cardioverter Defibrillator (ICD), model 1872	Repetitive mechanical stress applied to the titanium case can induce component damage and device malfunction in certain ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs. Devices implanted subcutaneously or in a subpectoral position with the serial number facing away from the ribs are not included in this advisory. This upd	accessdata.fda.gov
March 23, 2007	37769	Not yet classified	Terminated	CONTAK RENEWAL 3 (model H170, H175) CONTAK RENEWAL 3 HE (model H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.	Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than 3 months.	accessdata.fda.gov
March 16, 2007	44793	Not yet classified	Terminated	Guidant VITALITY VR/DR, Implantable Cardioverter Defibrillator, ICD, Models 1870 and 1871. Guidant VITALITY DR+, Implantable Cardioverter Defibrillator, ICD, Model 1872.	Atypical Charge Time Behavior: 1)-End of Life (EOL) or ERI is displayed during mid-life (typically 24-48 months), even though battery capacity remains available. 2)- Extended ERI charge time limits: Charge times during mid-life may remain below a normal extension of the ERI charge time. ****** Prophylactic replacement of these devices prior to ERI is not rec	accessdata.fda.gov
September 30, 2006	36495	Not yet classified	Terminated	Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219),CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D	Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed.	accessdata.fda.gov
June 24, 2006	35754	Not yet classified	Terminated	Guidant INSIGNIA I Entra-- family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). --Intermedics NEXUS Entra--fami	Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion or loss of pacing output without warning in the affected devices.	accessdata.fda.gov
May 19, 2006	35672	Not yet classified	Terminated	Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators. Guidant Corporation, 410	Final software load did not occur prior to shipment of select programmers.	accessdata.fda.gov
May 15, 2006	35537	Not yet classified	Terminated	Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK RENEWAL 4 HE (models H197, H199). Cardiac Resynchronization Therapy Defibrillator (	Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and bee	accessdata.fda.gov
May 15, 2006	35525	Not yet classified	Terminated	Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. C	Guidant has identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely.	accessdata.fda.gov
April 7, 2006	35166	Not yet classified	Terminated	Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO. Guidant Corporation, 4100 Hamline Avenue North, St. Paul, MN 55112-	77 distributed devices may have a cracked layer of insulation in a flexible hybrid circuit, leading to internal shorting during charging such as during routine capacitor formation or for defibrillation. This would likely render the device non-functional, resulting in no output and/or telemetry communications.	accessdata.fda.gov
March 11, 2006	34860	Not yet classified	Terminated	CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTAK RENEWAL 4 RF (models H230, H235) CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), pr	Guidant received 39 reports of devices that exhibited lower than expected battery voltage prior to implant; none of these devices were implanted.	accessdata.fda.gov
September 30, 2005	33716	Not yet classified	Terminated	CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue Nort	Devices manufactured with batteries built on April 26 or 27, 2005, by a single operator, may have battery welds that may have been performed at settings outside of typical manufacturing specifications at the supplier.	accessdata.fda.gov
September 22, 2005	33871	Not yet classified	Terminated	Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of	Another failure mode, which occurs at a low rate, has been identified with the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include; intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.	accessdata.fda.gov
September 22, 2005	33491	Not yet classified	Terminated	Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of	A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.	accessdata.fda.gov
July 25, 2005	32738	Not yet classified	Terminated	VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.	Guidant is revising its original recommendations set forth in the 06/17/05 physician letter because new information indicates that one of the original recommendations can increase the risk of a latching event, which may limit available therapy.	accessdata.fda.gov
July 18, 2005	32681	Not yet classified	Terminated	DISCOVERY (model nos. 1174, 1175, 1273, 1274 and 1275) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. DISCOVERY	A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.	accessdata.fda.gov
June 24, 2005	32496	Not yet classified	Terminated	CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model no. H177 and H179). Cardiac Resynchronization Therapy Defibrillator. Sterilized with gaseous ethylene oxide. Guidant Corporation, Ca	Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.	accessdata.fda.gov
June 17, 2005	32391	Not yet classified	Terminated	VENTAK PRIZM AVT model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.	The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.	accessdata.fda.gov
June 17, 2005	32380	Not yet classified	Terminated	CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue Nort	Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.	accessdata.fda.gov
June 17, 2005	32379	Not yet classified	Terminated	Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St.	Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjuction with other factors, resulted in an electrical short. The short caused diversion of shock therapy energy away from the heart and into device circuitry.	accessdata.fda.gov
June 16, 2005	32495	Not yet classified	Terminated	PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 5	Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.	accessdata.fda.gov
June 13, 2005	32395	Not yet classified	Terminated	Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/Defibrillation Lead. Guidant Corporation Cardiac Rhythm Management 4100 Hamline Avenue North, St. Paul, MN 55112-5798. Sterilized w	A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.	accessdata.fda.gov
March 11, 2004	28498	Not yet classified	Terminated	Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter.087'', 2.21 mm, Overall Length 54 cm, CS Wide Tip Shape, CS-W, REF 6705	The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.	accessdata.fda.gov
June 23, 2003	26561	Not yet classified	Terminated	Pulsar Max II Multiprogrammable Pacemaker, Model 1180	Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.	accessdata.fda.gov
May 6, 2003	26235	Not yet classified	Terminated	Pulsar Multiprogrammable Pacemaker, DDD Model 970	In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.	accessdata.fda.gov

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Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.