Data / Medical devices / United States / Boston Scientific Corporation
Boston Scientific Corporation: FDA-registered device maker in Marlborough, MA, United States, 167 510(k) clearances and 4 PMA approvals
Boston Scientific Corporation is registered with the FDA (registration 3005099803) in Marlborough, MA, United States. It lists 114 device types. The FDA files 167 510(k) clearances and 4 PMA approvals under its listings, the newest dated September 11, 2026. 82 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005099803
- Address
- 100 Boston Scientific Way, Marlborough, MA, United States, 01752
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- July 22, 1992
- Registered through
- 2027
- Brand names listed
- AMS 700 with Inhibizone, AMS 700 without Inhibizone, AMS 800 with Inhibizone, AMS 800 without Inhibizone, Alair Bronchial Thermoplasty Catheter, Alair Bronchial Thermoplasty Controller, Alair RF Controller Accessory Kit, Ambicor and more
Devices it lists
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 167.
| 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 4, 2026 | K261915 | Navigator Flex Ureteral Access Sheath Set | FED | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| June 17, 2026 | K260428 | RIVOS EUS Access Device (M00553900) | ODG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 27, 2026 | K251273 | Asurys Fluid Management System | HIG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| February 10, 2026 | K260119 | SpaceOAR Vue System (SV-2101) | OVB | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 9, 2025 | K252910 | Orca Air/Water and Suction Valves | ODC | Unknown | Boston Scientific | accessdata.fda.gov |
| September 26, 2025 | K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | BWH | 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 |
| 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 |
| July 3, 2025 | K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | FGE | Substantially Equivalent | Boston Scientific | 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 |
| 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 |
| February 6, 2025 | K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) | PKL | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 6, 2024 | K242950 | WallFlex Biliary PLUS RX Stent System | FGE | Unknown | Boston Scientific | accessdata.fda.gov |
| August 30, 2024 | K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | FGE | Unknown | Boston Scientific | 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 |
| April 29, 2024 | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | ESW | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| April 4, 2024 | K233837 | Agile Esophageal Stent System | ESW | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 8, 2024 | K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System | MQR | Substantially Equivalent | Boston Scientific Corporation | 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 |
| October 27, 2023 | K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) | KNS | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| September 18, 2023 | K232544 | Apollo ESG NXT System, Apollo REVISE NXT System | QTD | Substantially Equivalent | Apollo Endosurgery, Inc. | accessdata.fda.gov |
| August 14, 2023 | K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome | KNS | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| July 14, 2023 | K230269 | Ultraflex Tracheobronchial Stent System | JCT | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| June 29, 2023 | K231553 | OverStitch NXT Endoscopic Suturing System | OCW | Substantially Equivalent | Apollo Endosurgery, Inc. | 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 21, 2023 | K231533 | Habib EndoHPB | KNS | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| June 16, 2023 | K223890 | NAJA Gastrointestinal Catheter | FGD | Substantially Equivalent | Chess Medical, Inc. | accessdata.fda.gov |
| June 15, 2023 | K223469 | WallFlex Biliary RX Stent System | FGE | Unknown | Boston Scientific Corporation | accessdata.fda.gov |
| March 2, 2023 | K221340 | iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) | EOQ | 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 |
| December 29, 2022 | K223592 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | FGE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| September 14, 2022 | K222503 | Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip | PKL | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 4, 2022 | K221124 | MANTIS Clip | PKL | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| July 28, 2022 | K222014 | EXALT Model B Single-Use Bronchoscope | EOQ | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| July 12, 2022 | DEN210045 | APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System | QTD | Unknown | Apollo Endosurgery, Inc. | accessdata.fda.gov |
| May 6, 2022 | K212582 | SpyGlass Discover Balloon Dilation Catheter | GCA | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| February 21, 2022 | K203548 | EndoArmor + Surgical Gown | FYA | 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 |
| August 9, 2021 | K211030 | EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor | EOQ | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| May 26, 2021 | K203322 | SpyGlass Discover Retrieval Basket | LQR | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| May 6, 2021 | K210353 | AutoCap RX | ODC | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| April 27, 2021 | K211072 | Safety Trocar Cannula | KNT | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 2, 2021 | K210266 | OverStitch Sx Endoscopic Suturing System | OCW | Substantially Equivalent | Apollo Endosurgery, Inc. | accessdata.fda.gov |
| December 18, 2020 | K203162 | Advanix Biliary Stent with NaviFlex RX Delivery System | FGE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 15, 2020 | K201808 | X-Tack Endoscopic HeliX Tacking System | PKL | Substantially Equivalent | Apollo Endosurgery, Inc. | accessdata.fda.gov |
| December 3, 2020 | K200404 | ORISE ProKnife | KNS | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 8, 2020 | K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares | FDI | 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 |
| December 13, 2019 | K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller | FDT | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 29, 2019 | K191439 | OverStitch 2-0 Polypropylene Suture | OCW | Substantially Equivalent | Apollo Endosurgery | accessdata.fda.gov |
| July 25, 2019 | K191789 | Stonetome Stone Removal Device | LQR | Unknown | Boston Scientific Corporation | accessdata.fda.gov |
| July 19, 2019 | K182971 | SpaceOAR Vue Hydrogel | OVB | Substantially Equivalent | Augmenix, 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 |
| March 25, 2019 | K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System | PCU | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 8, 2019 | K183085 | CoreDx Pulmonary Mini-Forceps | EOQ | Substantially Equivalent | Boston Scientific Corporation | 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 |
| November 27, 2018 | K182169 | AdVance XP Male Sling | OTM | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| September 28, 2018 | K180068 | ORISE Gel | PLL | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| September 13, 2018 | K182275 | Seal Single Use Biopsy Valve | OCX | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| June 27, 2018 | K181141 | OverStitch Endoscopic Suturing System and Accessories | OCW | Substantially Equivalent | Apollo Endosurgery | accessdata.fda.gov |
| April 10, 2018 | K180530 | Imager II Urology Torque Catheter | KOD | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 10, 2018 | K172929 | Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath | LJE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 20, 2017 | K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | PWJ | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 19, 2017 | K173251 | LumiCoil Platinum Fiducial Marker | IYE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| December 15, 2017 | K171271 | Polyform Synthetic Mesh | OTO | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| November 3, 2017 | K172060 | Capio SLIM Suture Capturing Device | PWI | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 27, 2017 | K173184 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | ODG | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| October 4, 2017 | K172520 | CRE RX Biliary Balloon Dilatation Catheter | FGE | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| August 9, 2017 | K171809 | Epic Biliary Endoscopic Stent System | FGE | Unknown | Boston Scientific Corporation | accessdata.fda.gov |
| July 7, 2017 | K171454 | Interject Injection Therapy Needle Catheter | FBK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| June 23, 2017 | K170759 | CRE Pulmonary Balloon Dilatation Catheter | KTI | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 27, 2017 | K163248 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | EOQ | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 30, 2017 | K163058 | Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle | ODG | Substantially Equivalent | Boston Scientific | accessdata.fda.gov |
| June 27, 2016 | K161482 | EndoChoice Water Bottle Cap Irrigation System | FEQ | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
| June 17, 2016 | K161003 | EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector | PIF | Unknown | Boston Scientific Corporation | accessdata.fda.gov |
| May 19, 2016 | K160403 | SmartStart Air/Water and Suction Valves | ODC | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
| May 3, 2016 | K160845 | Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device | ODG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| March 30, 2016 | K160637 | Rotatable Snares | FDI | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| February 24, 2016 | K153588 | EndoChoice Water Bottle Cap System | FEQ | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
| December 10, 2015 | K152182 | Fuse Gastroscopy System | FDS | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
| November 13, 2015 | K153049 | LithoVue System | FGB | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| November 3, 2015 | K152580 | rescuenet | FDI | Substantially Equivalent | Endochoice, Inc. | accessdata.fda.gov |
| October 22, 2015 | K151895 | Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle | FCG | Substantially Equivalent | Boston Scientific Corporation | 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 |
| September 30, 2014 | K141598 | FUSE COLONOSCOPY SYSTEM | FDF | Substantially Equivalent | Endochoice, Inc. | 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 |
| April 2, 2014 | K133933 | INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER | KNS | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 24, 2014 | K133987 | CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES | FDI | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 8, 2014 | K133750 | OCCLUDER OCCLUSION BALLOON CATHETER | EYB | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| January 3, 2014 | K133312 | EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE | ODG | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| November 4, 2013 | K131700 | SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES | FDI | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| August 9, 2013 | K130484 | MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER | FGE | 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 |
| May 16, 2013 | K130909 | GATEWAY ADVANAGE Y-ADAPTER | OCX | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| January 16, 2013 | K121570 | AURIGA QI | GEX | Substantially Equivalent | Starmedtec GmbH | 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 |
|---|---|---|---|---|---|---|
| August 5, 2015 | P140008 | ORBERA INTRAGASTRIC BALLOON | LTI | 23 | January 5, 2026 | accessdata.fda.gov |
| April 27, 2010 | P080032 | ALAIR BRONCHIAL THERMOPLASTY SYSTEM | OOY | 20 | February 18, 2022 | accessdata.fda.gov |
| June 14, 2001 | P000053 | AMS SPHINCTER 800 URINARY CONTROL SYSTEM | EZY | 135 | September 14, 2026 | 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 10, 2026 | 99829 | Class II | Ongoing | NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030 | Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration. | accessdata.fda.gov |
| July 22, 2026 | 99630 | Class II | Ongoing | Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, | A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation. | accessdata.fda.gov |
| July 14, 2026 | 99435 | Class II | Ongoing | OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. | Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | accessdata.fda.gov |
| June 30, 2026 | 99336 | Class II | Ongoing | Rapid Refill Continuous Injection System, UPN M00566001 | Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the s | accessdata.fda.gov |
| June 30, 2026 | 99300 | Class II | Ongoing | Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: | Potential for breach in sterile barrier of device packaging. | accessdata.fda.gov |
| May 21, 2026 | 99067 | Class II | Ongoing | CRE Pro Wireguided 6-8mm 240cm | Potential sterile breach of the pouches in which devices are packaged. | accessdata.fda.gov |
| May 12, 2026 | 98970 | Class II | Ongoing | Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic | Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking. | accessdata.fda.gov |
| February 10, 2026 | 98412 | Class II | Ongoing | EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000 | Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components | accessdata.fda.gov |
| December 19, 2025 | 98237 | Class I | Ongoing | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660 | Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of even | accessdata.fda.gov |
| September 11, 2025 | 97603 | Class II | Ongoing | TENACIO Pump with InhibiZone; UPN: 72404429 | The potential for devices to experience inflation and/or deflation performance issues or difficulties. | accessdata.fda.gov |
| August 28, 2025 | 97529 | Class II | Ongoing | Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above) | The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa. | accessdata.fda.gov |
| December 20, 2024 | 96049 | Class II | Ongoing | AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640 | Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one. | accessdata.fda.gov |
| October 28, 2024 | 95608 | Class II | Ongoing | AMS Artificial Urinary Sphincter Control Pump | Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098) | accessdata.fda.gov |
| August 1, 2024 | 95124 | Class II | Ongoing | WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or e | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. | accessdata.fda.gov |
| June 27, 2024 | 94921 | Class II | Ongoing | Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture Capturing Devices are used by physicians to facilitate the consistent placement of sutures d | Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention. | accessdata.fda.gov |
| June 12, 2024 | 94827 | Class II | Ongoing | Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct. | Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure. | accessdata.fda.gov |
| February 20, 2024 | 94165 | Class II | Ongoing | EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509011 | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration | accessdata.fda.gov |
| December 19, 2023 | 93794 | Class II | Ongoing | EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. | Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae. | accessdata.fda.gov |
| September 27, 2023 | 93281 | Class II | Ongoing | EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0. | Poor image quality due to fluid ingress in the lens. | accessdata.fda.gov |
| May 25, 2023 | 92570 | Class II | Ongoing | Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Single-pack UPN : M006L8405910 | Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched | accessdata.fda.gov |
| February 2, 2023 | 91792 | Class II | Ongoing | Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts. UPN: M00 | Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is currently provided in the HABIB EndoHPB Catheter's Instructions for Use ("IFU"). | accessdata.fda.gov |
| October 10, 2022 | 90986 | Class II | Ongoing | ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision wi | Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting surgical intervention | accessdata.fda.gov |
| May 31, 2022 | 90458 | Class III | Ongoing | GreenLight HPSEA Laser Fibers, UPN 0010-2092 | Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced. | accessdata.fda.gov |
| March 3, 2022 | 89931 | Class II | Ongoing | EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures | Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device. | accessdata.fda.gov |
| February 24, 2022 | 89862 | Class II | Ongoing | SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to | Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue. | accessdata.fda.gov |
| December 22, 2021 | 89468 | Class II | Ongoing | Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040 | Sterility of device is compromised due to a sterile barrier breach | accessdata.fda.gov |
| October 21, 2021 | 88991 | Class II | Ongoing | HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890 | Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure | accessdata.fda.gov |
| April 15, 2021 | 87709 | Class II | Ongoing | Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210 | Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection | accessdata.fda.gov |
| March 26, 2021 | 87671 | Class II | Terminated | The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistan | An AMS mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal Reservoir with InhibiZone. | accessdata.fda.gov |
| March 16, 2021 | 87593 | Class III | Terminated | EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation. UPN: M00542430 | May have been programmed with a less than optimal brightness setting resulting in a darker than desired image | accessdata.fda.gov |
| January 19, 2021 | 87221 | Class II | Ongoing | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Bo | Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient. | accessdata.fda.gov |
| December 1, 2020 | 86909 | Class II | Terminated | AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-of | The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity | accessdata.fda.gov |
| November 16, 2020 | 86880 | Class II | Ongoing | Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570 | Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel. | accessdata.fda.gov |
| November 3, 2020 | 86847 | Class II | Ongoing | EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician | This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles. | accessdata.fda.gov |
| September 24, 2020 | 86562 | Class II | Ongoing | AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Inflatable Penile Prosthesis | The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation. | accessdata.fda.gov |
| September 22, 2020 | 86539 | Class II | Terminated | Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the proced | Incorrectly installed base. | accessdata.fda.gov |
| September 16, 2020 | 86476 | Class II | Ongoing | Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the | RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength. | accessdata.fda.gov |
| August 7, 2020 | 86226 | Class II | Terminated | WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of | Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device | accessdata.fda.gov |
| July 6, 2020 | 86004 | Class II | Ongoing | Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diamet | BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring interventi | accessdata.fda.gov |
| June 4, 2020 | 85815 | Class II | Terminated | Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. | The needle surface deteriorated due to unexpected electrolysis during procedure. | accessdata.fda.gov |
| March 30, 2020 | 85356 | Class II | Terminated | MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. | To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints. | accessdata.fda.gov |
| March 9, 2020 | 85227 | Class II | Ongoing | Sensor Nitinol Wire with Hydrophilic Tip.035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit | An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device | accessdata.fda.gov |
| December 17, 2019 | 84739 | Class II | Terminated | AMS mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). | A labeling discrepancy incorrectly labeled AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone as 100mL Spherical Reservoir with InhibiZone. | accessdata.fda.gov |
| November 18, 2019 | 84375 | Class II | Terminated | Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency gene | During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area d | accessdata.fda.gov |
| November 8, 2019 | 84363 | Class II | Terminated | AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H 105650-004R 105650-007R 105650-009R 105650-024H 105650-024Z 105650-025 105650-025H 105650-025R 1056 | Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual. | accessdata.fda.gov |
| October 21, 2019 | 84150 | Class II | Terminated | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 3cm UPN: M00536610 | Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life | accessdata.fda.gov |
| September 18, 2019 | 85271 | Class II | Completed | iLab Polaris Multi-Modality Guidance System; iLab Ultrasound Imaging System | Certain iLab Polaris Systems which were upgraded with a previous 2.10 software version (disk batch 629774) contained a bug in which only the True Color Secondary Capture (SC) format will archive Diastolic Hyperemia-Free Ratio data as intended. If either Multi-Frame UltraSound (US) or SC Image Storage formats are used, the DFR data will not be archived and th | accessdata.fda.gov |
| July 19, 2019 | 83567 | Class II | Terminated | AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161 | Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore.. | accessdata.fda.gov |
| April 8, 2019 | 82691 | Class II | Terminated | AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System including a fiber optic delivery system is intended to be used in surgical procedures such a | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop emitting laser pulses and enters a stand-by mode after a low power error message. | accessdata.fda.gov |
| December 26, 2018 | 82068 | Class II | Terminated | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220 | The sterile barrier may contain packaging seal defects. | accessdata.fda.gov |
| June 20, 2018 | 80501 | Class II | Ongoing | Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0 | Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released. | accessdata.fda.gov |
| February 12, 2018 | 79608 | Class II | Terminated | Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site. | Potential for Capio sutures to break and /or detach. | accessdata.fda.gov |
| December 20, 2017 | 79529 | Class II | Terminated | SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600 | Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding. | accessdata.fda.gov |
| December 12, 2017 | 79424 | Class II | Terminated | Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 08714729030980 The Malecot and the Stenting Malecot Catheters are designed for percutaneous drainage within the renal collecting system while maintai | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | accessdata.fda.gov |
| September 22, 2017 | 79096 | Class II | Terminated | Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures. | Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console. | accessdata.fda.gov |
| June 15, 2017 | 77820 | Class II | Terminated | Encore(TM) 26 Inflation Device, REF Catalog Nos.: (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140 | Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. | accessdata.fda.gov |
| June 1, 2017 | 77431 | Class II | Terminated | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300 | Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon | accessdata.fda.gov |
| May 15, 2017 | 77444 | Class II | Terminated | FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receiv | The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. | accessdata.fda.gov |
| March 18, 2016 | 73660 | Class II | Terminated | Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchi | Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm | accessdata.fda.gov |
| April 27, 2015 | 71137 | Class II | Terminated | Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remov | One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label. | accessdata.fda.gov |
| September 30, 2014 | 69404 | Class II | Terminated | StarMedTec LightTrail Reusable Fibers, 365 um; Material/Part Number: 6453 | Product is not cleared for use with lasers other than the Auriga XL system | accessdata.fda.gov |
| December 18, 2013 | 67139 | Class II | Terminated | Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) | Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size | accessdata.fda.gov |
| November 20, 2013 | 66907 | Class II | Terminated | TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Universal Product Number (UPN): M00561410. Distributed by: Boston Scientific. Manufactured by: Horizons International Corp. Intended to be used in fle | Sterility of device may be compromised due to lack of pouch seal integrity | accessdata.fda.gov |
| November 5, 2013 | 66828 | Class II | Terminated | Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for | The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports where the tip of the dilator has separated fro the body of the dilator. | accessdata.fda.gov |
| May 28, 2013 | 65347 | Class III | Terminated | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the | Product labeled with incorrect expiration date. | accessdata.fda.gov |
| May 28, 2013 | 65317 | Class II | Terminated | NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/, M062101440/210144 Dilation of the nephrostomy tract. | Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter. | accessdata.fda.gov |
| May 28, 2013 | 65303 | Class II | Terminated | Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA | Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label. | accessdata.fda.gov |
| September 17, 2012 | 63336 | Class II | Terminated | LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofre | Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified. | accessdata.fda.gov |
| May 16, 2012 | 61935 | Class II | Terminated | Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530, The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracte | Difficulty in extending snare loop from the catheter | accessdata.fda.gov |
| March 2, 2012 | 61377 | Not yet classified | Terminated | Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA. The Soloist Needle Electrode is intended for use in conjunc | Device found labeled with the incorrect expiration dates. The Soloist Single Needle Electrode has been qualified for a 3 year expiration date. Product manufactured between the dates of May 24, 2011 and November 8, 2011 has an incorrect expiration date of 20 years labeled on the pouched needle electrode and 5 years labeled on the carton. | accessdata.fda.gov |
| August 11, 2011 | 59743 | Not yet classified | Terminated | Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO The Expect Needle is designed to sample targeted submucosal and extramural gastrointestinal | The firm has determined that a single lot of 25 ga Expect EUS/FNA devices were mislabeled. The carton label incorrectly described the devices as 22 ga. The inner pouch label incorrectly describes the device as 25 ga. | accessdata.fda.gov |
| July 19, 2011 | 59476 | Not yet classified | Terminated | The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system. Endoscopic Clipping Device, Hemorrhoidal Ligator. The | Boston Scientific has received reports where, following clip deployment, the alignment of the clip and delivery system does not allow for the withdrawal of the delivery system away from the clip, resulting in tissue trauma, increased bleeding and the clip being pulled off tissue as the delivery system is withdrawn. | accessdata.fda.gov |
| May 10, 2011 | 58852 | Not yet classified | Terminated | Pinnacle Pelvic Floor Repair Kit--Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit--Posterior STERILE. Boston Scientific, Corp. Indicated for tissue reinforcement and stabilization of fascial structures of t | The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement. | accessdata.fda.gov |
| October 20, 2010 | 57317 | Not yet classified | Terminated | Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA (0.72 mm) sterile, UPN M00550010, 428 Technology Drive East, Menomonie, WI. Designed to sample targeted submucosal and extramural gastro | The firm has received a high number of complaints related to difficulty advancing and/or retracting the needle. | accessdata.fda.gov |
| July 15, 2010 | 56331 | Not yet classified | Terminated | Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release (18/23/15) Material/Catalog Number: M00513720. | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. | accessdata.fda.gov |
| May 17, 2010 | 55784 | Not yet classified | Terminated | Ultraflex Tracheobronchial Stent System. Uncovered - 8/20 Catalog Number: M00568920. Single Use, Rx only. Boston Scientific, Natick, MA 01760. Indicated for the use in the treatment of tracheobronchial structures produce | Suture related device failures during deployment and repositioning of the stent | accessdata.fda.gov |
| May 6, 2010 | 55740 | Not yet classified | Terminated | Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Inner Pouch 240cm, Box 20 UPN/Catalog Number: M00513331 | Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result. | accessdata.fda.gov |
| July 31, 2009 | 52780 | Not yet classified | Terminated | Boston Scientific HydroThermAblator Endometrial Ablation System- HTA Procedure Set (5/bx) Material/UPN/Catalog Number: M006550161 Boston Scientific HydroThermAblator Endometrial Ablation System-HTA Procedure Set (ea) Mat | Cracked procedure sheaths, incorrect care/use of device, and console malfunctions may result in fluid leaks and loss of a cervical seal that are responsible for burns. | accessdata.fda.gov |
| July 20, 2009 | 52715 | Not yet classified | Terminated | Prolieve Thermodilatation Catheter Kit, a Transurethral Microwave Therapy (TUMT) System, for BPH (Benign Prostatic Hyperplasia) Thermotherapy, Material Numbers M0068808022 and M0068808170. | Balloon leaks: Boston Scientific has received complaints from the field involving product leaks associated with the anchor balloons and compression balloons. Correspondence between BSC and FDA has led to BSC's decision to remove the Prolieve Catheter Kits from the field. | accessdata.fda.gov |
| September 10, 2007 | 44939 | Not yet classified | Terminated | Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303 | Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire. | accessdata.fda.gov |
| August 28, 2007 | 44736 | Not yet classified | Terminated | Boston Scientific Radial Jaw Large Capacity Biopsy Forceps, Sterile, 240 mm. Box of 20 U PN Number: M00513321 REF: 1332-20 | Device lacked manufacturing finishing process resulting in endoscope damage. | accessdata.fda.gov |
| July 28, 2005 | 32601 | Not yet classified | Terminated | Adapter for ACMI Hysteroscope Catalog Number: 55035 | The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak. | accessdata.fda.gov |
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Updated October 9, 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.