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Boston Scientific Corporation Recalls

383 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Boston Scientific Corporation.

383Total Recalls
91Critical
8.6MUnits Affected
Mar 30, 2026Most Recent
All Recalls

Every Boston Scientific Corporation Recall

Sorted by most recent. Click any recall for full details.

383 recalls
High RiskFDA
Boston Scientific Corporation
LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5
Medical Devices·2 affected·Mar 30, 2026
High RiskFDA
Boston Scientific Corporation
LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER ...
Medical Devices·148 affected·Mar 30, 2026
CriticalFDA
Boston Scientific Corporation
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL M...
Cardiac Devices·685,776 affected·Mar 19, 2026
CriticalFDA
Boston Scientific Corporation
Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO ...
Medical Implants·718,456 affected·Mar 19, 2026
CriticalFDA
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Medical Implants·266 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Medical Implants·557 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Medical Implants·588 affected·Dec 19, 2025
CriticalFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Medical Implants·39 affected·Dec 19, 2025
High RiskFDA
Boston Scientific Corporation
TENACIO Pump without InhibiZone; UPN: 72404420;
Medical Devices·0 affected·Sep 11, 2025
High RiskFDA
Boston Scientific Corporation
TENACIO Pump with InhibiZone; UPN: 72404429;
Medical Devices·59 affected·Sep 11, 2025
High RiskFDA
Boston Scientific Corporation
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);
Medical Devices·0 affected·Sep 11, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L211 PROPONENT DR SL MRI Pacemaker
Cardiac Devices·106,536 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number S702, ALTRUA 2 DR SL Pacemaker
Cardiac Devices·4,055 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U128, VALITUDE CRT-P EL MRI
Medical Devices·28,911 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L231, PROPONENT DR EL MRI Pacemaker
Cardiac Devices·63,851 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L101, ESSENTIO DR SL Pacemaker
Cardiac Devices·22,714 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Cardiac Devices·3,146 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U226, VISIONIST CRT-P EL
Medical Devices·1,050 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
PROPONENT SR SL (Model L200)
Medical Devices·1,380 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number U228, VISIONIST CRT-P EL MRI
Medical Devices·41,191 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L221 PROPONENT DR EL Pacemaker
Cardiac Devices·3,592 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Cardiac Devices·190,088 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
ACCOLADE DR EL MRI (Model L331)
Medical Devices·34,180 affected·Aug 20, 2025
CriticalFDA
Boston Scientific Corporation
Model Number L121 ESSENTIO DR EL Pacemaker
Cardiac Devices·10,833 affected·Aug 20, 2025
High RiskFDA
Boston Scientific Corporation
ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
Medical Devices·18 affected·Aug 18, 2025
High RiskFDA
Boston Scientific Corporation
Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Medical Devices·1 affected·Aug 18, 2025
High RiskFDA
Boston Scientific Corporation
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Medical Devices·458 affected·Aug 5, 2025
High RiskFDA
Boston Scientific Corporation
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5....
Medical Devices·1,369 affected·Aug 5, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WA...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the ...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WA...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the fa...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to provide vascular and transseptal access for all W...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the fa...
Medical Devices·340,185 affected·Jul 29, 2025
CriticalFDA
Boston Scientific Corporation
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, ...
Cardiac Devices·247,702 affected·Jul 24, 2025
CriticalFDA
Boston Scientific Corporation
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655...
Cardiac Devices·247,702 affected·Jul 24, 2025
High RiskFDA
Boston Scientific Corporation
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Surgical Devices·445 affected·Jun 25, 2025
High RiskFDA
Boston Scientific Corporation
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Use...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/4...
Medical Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and co...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 4...
Cardiac Devices·14,724 affected·Jun 10, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a ...
Medical Devices·31 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a ve...
Medical Devices·67 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a v...
Medical Devices·435 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Medical Implants·12 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Medical Implants·519 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
Medical Implants·1,102 affected·Dec 20, 2024
High RiskFDA
Boston Scientific Corporation
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
Medical Implants·1,530 affected·Dec 20, 2024