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Boston Scientific Corporation

890 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. recall (Z-2961-2026)Boston Scientific Corporation2026-08-14
Suture Cinch Long 1pk. Endoscopic tissue approximation device. recall (Z-2962-2026)Boston Scientific Corporation2026-08-14
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. recall (Z-2838-2026)Boston Scientific Corporation2026-07-31
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Rad recall (Z-2839-2026)Boston Scientific Corporation2026-07-31
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Ju recall (Z-2840-2026)Boston Scientific Corporation2026-07-31
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Rad recall (Z-2771-2026)Boston Scientific Corporation2026-07-22
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and int recall (Z-2754-2026)Boston Scientific Corporation2026-07-20
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into th recall (Z-2755-2026)Boston Scientific Corporation2026-07-20
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and recall (Z-2756-2026)Boston Scientific Corporation2026-07-20
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and int recall (Z-2757-2026)Boston Scientific Corporation2026-07-20
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percut recall (Z-2750-2026)Boston Scientific Corporation2026-07-17
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac recall (Z-2751-2026)Boston Scientific Corporation2026-07-17
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter recall (Z-2752-2026)Boston Scientific Corporation2026-07-17
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percut recall (Z-2753-2026)Boston Scientific Corporation2026-07-17
Rapid Refill Continuous Injection System, UPN M00566001 recall (Z-2725-2026)Boston Scientific Corporation2026-07-10
CRE Pro Wireguided 6-8mm 240cm recall (Z-2626-2026)Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 8-10mm 240cm recall (Z-2627-2026)Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 10-12mm 240cm recall (Z-2628-2026)Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 12-15mm 240cm recall (Z-2629-2026)Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 15-18mm 240cm recall (Z-2630-2026)Boston Scientific Corporation2026-07-01
CRE Pro Wireguided 18-20mm 240cm recall (Z-2631-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 6-8mm 240cm recall (Z-2632-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 8-10mm 240cm recall (Z-2633-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 10-12mm 240cm recall (Z-2634-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 12-15mm 240cm recall (Z-2635-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 15-18mm 240cm recall (Z-2636-2026)Boston Scientific Corporation2026-07-01
CRE Wireguided 18-20mm 240cm recall (Z-2637-2026)Boston Scientific Corporation2026-07-01
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug deliv recall (Z-2580-2026)Boston Scientific Corporation2026-06-25
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca A recall (Z-2413-2026)Boston Scientific Corporation2026-06-11
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Mo recall (Z-2048-2026)Boston Scientific Corporation2026-05-01
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON E recall (Z-2049-2026)Boston Scientific Corporation2026-05-01
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synch recall (Z-1770-2026)Boston Scientific Corporation2026-04-24
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, recall (Z-1771-2026)Boston Scientific Corporation2026-04-24
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Nu recall (Z-1551-2026)Boston Scientific Corporation2026-03-11
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UP recall (Z-1158-2026)Boston Scientific Corporation2026-02-05
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN) recall (Z-1159-2026)Boston Scientific Corporation2026-02-05
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN) recall (Z-1160-2026)Boston Scientific Corporation2026-02-05
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UP recall (Z-1161-2026)Boston Scientific Corporation2026-02-05
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (U recall (Z-1162-2026)Boston Scientific Corporation2026-02-05
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number recall (Z-1163-2026)Boston Scientific Corporation2026-02-05
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, recall (Z-1042-2026)Boston Scientific Corporation2026-01-09
ACCOLADE SR SL (Model L300) recall (Z-0079-2026)Boston Scientific Corporation2025-10-10
ACCOLADE DR SL (Model L301) recall (Z-0080-2026)Boston Scientific Corporation2025-10-10
ACCOLADE SR SL MRI (Model L310) recall (Z-0081-2026)Boston Scientific Corporation2025-10-10
ACCOLADE DR SL MRI (Model L311) recall (Z-0082-2026)Boston Scientific Corporation2025-10-10
ACCOLADE DR EL (Model L321) recall (Z-0083-2026)Boston Scientific Corporation2025-10-10
ACCOLADE DR EL MRI (Model L331) recall (Z-0084-2026)Boston Scientific Corporation2025-10-10
PROPONENT SR SL (Model L200) recall (Z-0085-2026)Boston Scientific Corporation2025-10-10
PROPONENT DR SL (Model L201) recall (Z-0086-2026)Boston Scientific Corporation2025-10-10
Model Number L209 PROPONENT DR (VDD) SL Pacemaker recall (Z-0087-2026)Boston Scientific Corporation2025-10-10
Model Number L210 PROPONENT SR SL Pacemaker recall (Z-0088-2026)Boston Scientific Corporation2025-10-10
Model Number L211 PROPONENT DR SL MRI Pacemaker recall (Z-0089-2026)Boston Scientific Corporation2025-10-10
Model Number L221 PROPONENT DR EL Pacemaker recall (Z-0090-2026)Boston Scientific Corporation2025-10-10
Model Number L231, PROPONENT DR EL MRI Pacemaker recall (Z-0091-2026)Boston Scientific Corporation2025-10-10
Model Number L100, ESSENTIO SR SL Pacemaker recall (Z-0092-2026)Boston Scientific Corporation2025-10-10
Model Number L101, ESSENTIO DR SL Pacemaker recall (Z-0093-2026)Boston Scientific Corporation2025-10-10
Model Number L110, ESSENTIO SR SL MRI Pacemaker recall (Z-0094-2026)Boston Scientific Corporation2025-10-10
Model Number L111, ESSENTIO DR SL MRI Pacemaker recall (Z-0095-2026)Boston Scientific Corporation2025-10-10
Model Number L121 ESSENTIO DR EL Pacemaker recall (Z-0096-2026)Boston Scientific Corporation2025-10-10
Model Number L131, ESSENTIO DR EL MRI Pacemaker recall (Z-0097-2026)Boston Scientific Corporation2025-10-10
Model Number S701 ALTRUA 2 SR SL Pacemaker recall (Z-0098-2026)Boston Scientific Corporation2025-10-10
Model Number S702, ALTRUA 2 DR SL Pacemaker recall (Z-0099-2026)Boston Scientific Corporation2025-10-10
Model Number S722, ALTRUA 2 DR EL Pacemaker recall (Z-0100-2026)Boston Scientific Corporation2025-10-10
Model Number U125, VALITUDE CRT-P EL recall (Z-0101-2026)Boston Scientific Corporation2025-10-10
Model Number U128, VALITUDE CRT-P EL MRI recall (Z-0102-2026)Boston Scientific Corporation2025-10-10
Model Number U225 VISIONIST CRT-P EL recall (Z-0103-2026)Boston Scientific Corporation2025-10-10
Model Number U226, VISIONIST CRT-P EL recall (Z-0104-2026)Boston Scientific Corporation2025-10-10
Model Number U228, VISIONIST CRT-P EL MRI recall (Z-0105-2026)Boston Scientific Corporation2025-10-10
TENACIO Pump with InhibiZone; UPN: 72404429; recall (Z-0138-2026)Boston Scientific Corporation2025-10-10
TENACIO Pump without InhibiZone; UPN: 72404420; recall (Z-0139-2026)Boston Scientific Corporation2025-10-10
CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 7240 recall (Z-0140-2026)Boston Scientific Corporation2025-10-10
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 724 recall (Z-0141-2026)Boston Scientific Corporation2025-10-10
CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) recall (Z-0142-2026)Boston Scientific Corporation2025-10-10
CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2 recall (Z-0143-2026)Boston Scientific Corporation2025-10-10
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2 recall (Z-0144-2026)Boston Scientific Corporation2025-10-10
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) recall (Z-2618-2025)Boston Scientific Corporation2025-09-23
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Number recall (Z-2550-2025)Boston Scientific Corporation2025-09-11
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 recall (Z-2551-2025)Boston Scientific Corporation2025-09-11
Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. recall (Z-2533-2025)Boston Scientific Corporation2025-09-05
Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904 recall (Z-2534-2025)Boston Scientific Corporation2025-09-05
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. ( recall (Z-2535-2025)Boston Scientific Corporation2025-09-05
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210 recall (Z-2536-2025)Boston Scientific Corporation2025-09-05
WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to pr recall (Z-2426-2025)Boston Scientific Corporation2025-08-29
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to pr recall (Z-2427-2025)Boston Scientific Corporation2025-08-29
WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to pr recall (Z-2428-2025)Boston Scientific Corporation2025-08-29
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to pro recall (Z-2429-2025)Boston Scientific Corporation2025-08-29
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to pro recall (Z-2430-2025)Boston Scientific Corporation2025-08-29
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to pro recall (Z-2431-2025)Boston Scientific Corporation2025-08-29
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to pro recall (Z-2432-2025)Boston Scientific Corporation2025-08-29
WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to pro recall (Z-2433-2025)Boston Scientific Corporation2025-08-29
WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to p recall (Z-2434-2025)Boston Scientific Corporation2025-08-29
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to p recall (Z-2435-2025)Boston Scientific Corporation2025-08-29
WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide recall (Z-2436-2025)Boston Scientific Corporation2025-08-29
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrill recall (Z-2325-2025)Boston Scientific Corporation2025-08-20
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent De recall (Z-2326-2025)Boston Scientific Corporation2025-08-20
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent recall (Z-2327-2025)Boston Scientific Corporation2025-08-20
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and sten recall (Z-2273-2025)Boston Scientific Corporation2025-08-08
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 recall (Z-2278-2025)Boston Scientific Corporation2025-08-08
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45D recall (Z-2103-2025)Boston Scientific Corporation2025-07-10
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. recall (Z-2104-2025)Boston Scientific Corporation2025-07-10
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Every clearance here is in the API, with alerts when new ones post.