Data / Medical devices / United States / Boston Scientific Corp., Marina Bay Cust. Fulfillment Center

Boston Scientific Corp., Marina Bay Cust. Fulfillment Center: FDA-registered device maker in Quincy, MA, United States, 61 510(k) clearances and 11 PMA approvals

Name: Boston Scientific Corp., Marina Bay Cust. Fulfillment Center FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Boston Scientific Corp., Marina Bay Cust. Fulfillment Center is registered with the FDA (registration 1225687) in Quincy, MA, United States. It lists 52 device types. The FDA files 61 510(k) clearances and 11 PMA approvals under its listings, the newest dated September 3, 2026. 39 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 1225687
FEI number: 3001451463
Address: 500 Commander Shea Boulevard, Quincy, MA, United States, 02171
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed: August 1, 2005
Registered through: 2027
Brand names listed: AGENT Paclitaxel-Coated Balloon Catheter, Connector Tools, ELUVIA Drug-Eluting Vascular Stent System, ENDOTAK RELIANCE, ENDOTAK RELIANCE G, ENDOTAK RELIANCE S, ENDOTAK RELIANCE SG, Emerge PTCA Dilatation Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	NOY	2	Manufacturer	accessdata.fda.gov
Agents, Embolic, For Treatment Of Uterine Fibroids	NAJ	2	Manufacturer	accessdata.fda.gov
Aspiration Thrombectomy Catheter	QEZ	2	Manufacturer	accessdata.fda.gov
Biopsy Needle	FCG	2	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer	accessdata.fda.gov
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Manufacturer	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Manufacturer	accessdata.fda.gov
Catheter, Coronary, Atherectomy	MCX	3	Manufacturer	accessdata.fda.gov
Catheter, Nephrostomy	LJE	U	Manufacturer	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Catheter, Peripheral, Atherectomy	MCW	2	Manufacturer	accessdata.fda.gov
Catheter, Septostomy	DXF	2	Manufacturer	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Manufacturer	accessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, Percutaneous	LOX	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Choledochoscope And Accessories, Flexible/Rigid	FBN	2	Manufacturer	accessdata.fda.gov
Collagen Surgical Mesh Containing Drugs	PIJ	2	Manufacturer	accessdata.fda.gov
Coronary Drug-Eluting Stent	NIQ	3	Manufacturer	accessdata.fda.gov
Device, Neurovascular Embolization	HCG	2	Manufacturer	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Manufacturer	accessdata.fda.gov
Dilator, Catheter, Ureteral	EZN	2	Manufacturer	accessdata.fda.gov
Dilator, Urethral	KOE	2	Manufacturer	accessdata.fda.gov
Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter	OOB	3	Manufacturer	accessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty Catheter	ONU	3	Manufacturer	accessdata.fda.gov
Endoscopic Cholangiogram Kit	NWT	2	Manufacturer	accessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-Urology	ODG	2	Manufacturer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Manufacturer	accessdata.fda.gov
Hydrogel Spacer	OVB	2	Manufacturer	accessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)	LWS	3	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Led Light Source	NTN	2	Manufacturer	accessdata.fda.gov
Lithotriptor, Electro-Hydraulic	FFK	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Mesh, Surgical	FTM	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, For Stress Urinary Incontinence, Male	OTM	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Polymeric	FTL	2	Manufacturer	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Manufacturer	accessdata.fda.gov
Permanent Defibrillator Electrodes	NVY	3	Manufacturer	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Manufacturer	accessdata.fda.gov
Prosthesis, Esophageal	ESW	2	Manufacturer	accessdata.fda.gov
Snare, Flexible	FDI	2	Manufacturer	accessdata.fda.gov
Stent, Coronary	MAF	3	Manufacturer	accessdata.fda.gov
Stent, Iliac	NIO	3	Manufacturer	accessdata.fda.gov
Stent, Superficial Femoral Artery	NIP	3	Manufacturer	accessdata.fda.gov
Stent, Superficial Femoral Artery, Drug-Eluting	NIU	3	Manufacturer	accessdata.fda.gov
Stent, Ureteral	FAD	2	Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Manufacturer	accessdata.fda.gov
System, Appendage Closure, Left Atrial	NGV	3	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov
Tube, Drainage, Suprapubic	FFA	2	Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Manufacturer	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 3, 2026	K262460	Rezum System	KNS	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
August 12, 2026	K262406	EluPro Antibiotic-Eluting BioEnvelope	FTM	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
February 10, 2026	K260119	SpaceOAR Vue System (SV-2101)	OVB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 11, 2025	K250584	Rezum System	KNS	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
April 29, 2024	K233939	Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System	ESW	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
August 8, 2023	K223633	Rubicon Control Support Catheter (H749394323506A1)	DQY	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
December 30, 2022	K223616	Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device	ODG	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 26, 2022	K222281	Intracept Intraosseous Nerve Ablation System	GXI	Substantially Equivalent	Relievant Medsystems, Inc.	accessdata.fda.gov
April 12, 2022	K213398	EMBOLD Fibered Detachable Coil System	KRD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 20, 2021	K211847	AdVance XP Male Sling System	OTM	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
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
May 21, 2020	K200483	SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller	FBN	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 17, 2020	K200733	Opticross 35 15 MHz Peripheral Imaging Catheter	ITX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 19, 2019	K182971	SpaceOAR Vue Hydrogel	OVB	Substantially Equivalent	Augmenix, 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
January 22, 2019	K183636	SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller	FBN	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 14, 2018	K180369	Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)	GXI	Substantially Equivalent	Relievant Medsystems	accessdata.fda.gov
October 27, 2017	K173184	Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle	ODG	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
January 30, 2017	K163058	Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle	ODG	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
June 23, 2016	K160823	NC Quantum Apex PTCA Dilatation Catheter	LOX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 3, 2016	K160845	Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device	ODG	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 21, 2015	K151313	ZelanteDVT Thrombectomy Set	QEW	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 17, 2015	K150709	ProTrack RF Anchor Wire	DXF	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
May 29, 2015	K150679	EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector	PIF	Unknown	Boston Scientific Corp	accessdata.fda.gov
August 27, 2014	K133023	JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6	MCW	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
August 22, 2014	K141597	MUSTANG BALLOON DIALATION CATHETER	FGE	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 21, 2014	K141521	MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER	LIT	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 21, 2014	K140726	CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV	FDI	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
February 14, 2014	K133629	ANGIOJET ULTRA AVX THROMBECTOMY SET	QEW	Substantially Equivalent	Possis Medical, Inc.	accessdata.fda.gov
January 3, 2014	K133312	EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE	ODG	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 29, 2013	K130381	ANGIOJET ULTRA POWER PULSE KIT	QEW	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
July 10, 2013	K130391	EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT	LOX	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
May 22, 2013	K130804	UROMAX ULTRA BALLOON DILATATION CATHETER	EZN	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 8, 2012	K122795	STINGRAY GUIDEWIRES	DQX	Substantially Equivalent	Bridgepoint Medical	accessdata.fda.gov
September 18, 2012	K121614	NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER	LJE	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
August 31, 2012	K121196	EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)	LOX	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
August 13, 2012	K121667	NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)	LOX	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
June 6, 2012	K113363	ANGIOJET SOLENT DISTA THROMBECTOMY SET	QEZ	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
March 22, 2012	K113220	EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE)	LOX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 14, 2011	K112198	EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE	ODG	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 2, 2011	K111288	ANCHORWIRE GUIDEWIRE	DQX	Substantially Equivalent	Lake Region Medical	accessdata.fda.gov
May 24, 2011	K111182	ANGIOJET SOLENT OMNI THROMBECTOMY SET	QEZ	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
May 12, 2011	K110122	MUSTANG BALLOON DILATAION CATHETERS	FGE	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
May 10, 2011	K102725	CROSSBOSS CATHETER MODEL M-2000, STINGRAY ORIENTING BALLOON CATHETER MODEL M-1000, STINGRAY GUIDEWIRE MODEL M-3004 AND M	DQY	Substantially Equivalent	Bridge Medical, Inc.	accessdata.fda.gov
January 12, 2011	K110030	EXPECT ENDOSCOPIC ASPIRATION NEEDLE	ODG	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
June 16, 2010	K101406	ANGIOJET SOLENT PROXI THROMBECTOMY SET MODEL 109676-001	QEZ	Substantially Equivalent	Medrad Interventional/Possis	accessdata.fda.gov
April 16, 2010	K094018	LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES	HCG	Substantially Equivalent	Biocompatibles UK Limited	accessdata.fda.gov
June 26, 2009	K091510	WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730	ESW	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 24, 2008	K083091	LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES	KRD	Substantially Equivalent	Biocompatibles UK Limited	accessdata.fda.gov
May 28, 2008	K073326	NRG TRANSSEPTAL NEEDLE	DXF	Substantially Equivalent	Baylis Medical Co., Inc.	accessdata.fda.gov
April 4, 2008	K080806	ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608	QEZ	Substantially Equivalent	Possis Medical, Inc.	accessdata.fda.gov
February 27, 2008	K073266	WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM	ESW	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
November 14, 2007	K072769	ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS	QEZ	Substantially Equivalent	Possis Medical, Inc.	accessdata.fda.gov
August 24, 2001	K012445	EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)	FFK	Substantially Equivalent	Electro Medical Systems SA	accessdata.fda.gov
December 8, 1994	K944290	CATHETERS, BILIARY CATHETERS, UROLOGICAL	FFA	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
January 26, 1994	K924608	HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS	FGE	Substantially Equivalent	Boston Scientific Corp	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
October 30, 2020	P190019	Ranger Paclitaxel-Coated PTA Balloon Catheter	ONU	41	August 4, 2026	accessdata.fda.gov
September 18, 2018	P180011	Eluvia Drug-Eluting Vascular Stent System	NIU	67	August 21, 2026	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
March 13, 2015	P130013	WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY	NGV	84	August 28, 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
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

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
August 24, 2020	86466	Class II	Terminated	Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Material Number (UPN) # H7493932800350 UDI # 08714729984542 Lot #25754545; 25852104; 2582106; 25856700	Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for anoth	accessdata.fda.gov
April 27, 2010	55855	Not yet classified	Terminated	FLEXIMA Biliary Stent System, 7Fr-12cm, M00539230, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, f	Flexima Biliary Stent System Devices were packaged with Tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. The breach of the sterility barrier could lead to the device being non-sterile.	accessdata.fda.gov
June 17, 2009	52565	Not yet classified	Terminated	Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00522602 (20 clips). Th	The clip may not deploy or, if deployed, the clip may not release from the tissue.	accessdata.fda.gov
June 17, 2008	48698	Not yet classified	Terminated	EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.	Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG	accessdata.fda.gov
February 7, 2008	46785	Not yet classified	Terminated	Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm,.070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, Sterile EO, Availmed S.A. de C.V. (Mexico), Boston Scientifi	Mislabeled: Seven lots/ batches of Boston Scientific Mach 1 Guide Catheter may be mislabeled with the incorrect device length.	accessdata.fda.gov
November 30, 2007	46330	Not yet classified	Terminated	Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760	Sheath Removal Difficulty: Users experience difficulty in removing the sheath.	accessdata.fda.gov
October 12, 2007	45432	Not yet classified	Terminated	Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, 8 & 9, Annacotty Busi	Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.	accessdata.fda.gov
June 4, 2007	38112	Not yet classified	Terminated	Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters. Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, Baja California 22650 ME	Labels on the carton from two batches/lots of Impulse Angiographic Catheters may indicate a different curve style than the device that is actually in the carton.	accessdata.fda.gov
May 1, 2007	48607	Not yet classified	Terminated	Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm REF 38928-1530 Lot 9565194 Use before 2010-04 Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis	The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.	accessdata.fda.gov
May 1, 2007	38117	Not yet classified	Terminated	Boston Scientific NexStent Monorail 5F Carotid Stent and Monorail Delivery System, Manufactured by: Endotex International Systems, Inc. 10231 Bubb Road Cupertino, CA 95014 USA	Boston Scientific NexStent Carotid Stent device failed to deploy when the outer catheter (proximal outer and distal sheath) did not pull back and expose the self-expanding stent.	accessdata.fda.gov
April 11, 2007	37886	Not yet classified	Terminated	Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110	Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit	accessdata.fda.gov
February 7, 2007	37403	Not yet classified	Terminated	Boston Scientific SpyGlass Visualization Probe Reference Number: 4603 UPN M00546030	SpyGlass Probe and Ocular: Ocular is out of specification and during disconnect may damage probe	accessdata.fda.gov
January 24, 2007	37291	Not yet classified	Terminated	HTA Console System, 110 Volt, Product Number: 56000 (HTA system is a software-controlled hysteroscopic thermal endometrial ablation system)	Defective integrated circuit board could result in loss of the system pump and patient injury (hot fluid 90 degree C into uterus) if in use during the recirculation/heating phase of treatment	accessdata.fda.gov
December 20, 2006	37068	Not yet classified	Terminated	Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100	Guidewire restriction during use (excessive adhesive in the guidewire lumen)	accessdata.fda.gov
November 1, 2005	48608	Not yet classified	Terminated	Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm Made in Ireland Ballybrit Business Park, Galway, Ireland REF 38928-1225 Use before 2007-01 UPN H7493892812250 Sterilized with ethylene ox	Two lots may not be correctly labeled. Specifically, a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.	accessdata.fda.gov
October 28, 2005	33858	Not yet classified	Terminated	Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050. Firm on label: Boston Scientific/Medi-Tech, Watertown, MA 02472	Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.	accessdata.fda.gov
October 25, 2005	33993	Not yet classified	Terminated	TLC Self -Retaining Retractor System-Single Product Code:	Sterility of device compromised due to breach in packaging	accessdata.fda.gov
September 23, 2005	33529	Not yet classified	Terminated	Enteryx Procedure Kit Order No.: M00572600 -US and M00572500 -OUS	Incorrect implantation may cause serious health complications	accessdata.fda.gov
August 10, 2005	36507	Not yet classified	Terminated	Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990	Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04	accessdata.fda.gov
July 22, 2005	32694	Not yet classified	Terminated	Banana Peel Sheaths BP/9/15 Catalog Number: 20-606	The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.	accessdata.fda.gov
June 27, 2005	32513	Not yet classified	Terminated	Hemashield Vantage Vascular Graft. Vascular graft prosthesis.	During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.	accessdata.fda.gov
June 8, 2005	32167	Not yet classified	Terminated	Vaxcel Plastic Low Profile Port (non-valved) chest port, with 6Fr Polyurethane Catheter, Catalog 45-333, Material #M001453330. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Fa	Potential for port housing separation after implantation.	accessdata.fda.gov
February 25, 2005	31251	Not yet classified	Terminated	Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Pl	Potential separation of the port base from the port cover after implantation.	accessdata.fda.gov
November 22, 2004	30572	Not yet classified	Terminated	VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN #M001454500; sold as individual catheters. Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA. Manufacture	Catheter separation immediately distal to the nose of the suture wing.	accessdata.fda.gov
August 9, 2004	29795	Not yet classified	Terminated	Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge, Catalog #40-102, Material #M001401021 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street, Watertown, MA 0247	Incomplete graduation on the needle guard, which would cause the graduations to be off by as much as 1 cm.	accessdata.fda.gov
July 16, 2004	29581	Not yet classified	Terminated	Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon.	Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.	accessdata.fda.gov
May 25, 2004	32271	Not yet classified	Terminated	PASV Central Venous Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central Venous Catheter is a packaged configuration comprised of a silicone Central Venous Catheter with PASV Valve, Guidewire, Syrin	Kits labeled to contain 0.028" guidewire contain 0.038" guidewire.	accessdata.fda.gov
March 29, 2004	28675	Not yet classified	Terminated	Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801.	Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.	accessdata.fda.gov
March 5, 2004	31811	Not yet classified	Terminated	PASV PICC Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CK, Material Number M001PIC402CK0. Responsible firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801 USA	Lumens may have incorrect lumen size marked on them.	accessdata.fda.gov
March 5, 2004	28533	Not yet classified	Terminated	VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (4 Fr), a 21 Ga. echogenic entry needle, and a.018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-988. Firm on the label: Boston	Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.	accessdata.fda.gov
February 10, 2004	28398	Not yet classified	Terminated	Vaxcel Port with PASV Valve, 8 Fr polyurethane catheter, Mini Titanium port, Implantable Port System, Model # M001452150, Catalog #45-215	Reports of catheter separation/fracture after implantation resulting in distal migration of the catheter.	accessdata.fda.gov
January 28, 2004	28313	Not yet classified	Terminated	Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965	Incorrect label states stent covered with 'Permalume Covering', product is uncovered	accessdata.fda.gov
July 3, 2003	26713	Not yet classified	Terminated	ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250	Sterility of the device may be compromised due to a lack of package integrity	accessdata.fda.gov
June 26, 2003	26644	Not yet classified	Terminated	Wallstent Enteral Endoprothesis with Unistep Plus Delivery, 20 mm X 90 mm Catalog Number: 6557	Mislabeled: Product is labeled as a 20 mm X 90 mm, but is actually a 22 mm X 60 mm	accessdata.fda.gov
June 23, 2003	26601	Not yet classified	Terminated	Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm Catalog no. 372403	Product 's Outer box label may not match pouch label: a 4mm x 30 mm coil may be labeled as a 9 mm x 60 mm or vice versa	accessdata.fda.gov
April 29, 2003	26206	Not yet classified	Terminated	MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr	Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr	accessdata.fda.gov
April 16, 2003	26136	Not yet classified	Terminated	Polyflex Esophageal Stent 20/16mm x 90mm	Radiopaque marker bands may not be visible under fluoroscopy	accessdata.fda.gov
March 17, 2003	25812	Not yet classified	Terminated	Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm) Product Number:	Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use	accessdata.fda.gov
January 29, 2003	25487	Not yet classified	Terminated	Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/8.5 mm balloon Catalog # 4544	Breach in sterile barrrier may compromise sterility	accessdata.fda.gov

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Updated September 3, 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.