Boston Scientific recalls
Boston Scientific appears in 655 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L221 PROPONENT DR EL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L100, ESSENTIO SR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number U225 VISIONIST CRT-P EL
FDA Device · Class I · 2025-10-22 · Boston Scientific - PROPONENT SR SL (Model L200)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number S701 ALTRUA 2 SR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - PROPONENT DR SL (Model L201)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number U226, VISIONIST CRT-P EL
FDA Device · Class I · 2025-10-22 · Boston Scientific - ACCOLADE DR SL (Model L301)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number U228, VISIONIST CRT-P EL MRI
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L209 PROPONENT DR (VDD) SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - TENACIO Pump with InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - ACCOLADE SR SL MRI (Model L310)
FDA Device · Class I · 2025-10-22 · Boston Scientific - ACCOLADE DR SL MRI (Model L311)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number U128, VALITUDE CRT-P EL MRI
FDA Device · Class I · 2025-10-22 · Boston Scientific - LGX Preconnect with TENACIO Pump without InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - CXR Preconnect with TENACIO Pump with InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - ACCOLADE SR SL (Model L300)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number S702, ALTRUA 2 DR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number S722, ALTRUA 2 DR EL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L210 PROPONENT SR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - LGX Preconnect with TENACIO Pump with InhibiZone
FDA Device · Class II · 2025-10-22 · Boston Scientific - ACCOLADE DR EL MRI (Model L331)
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L101, ESSENTIO DR SL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Model Number L121 ESSENTIO DR EL Pacemaker
FDA Device · Class I · 2025-10-22 · Boston Scientific - Extractor Pro RX Retrieval Balloon Catheter
FDA Device · Class II · 2025-10-01 · Boston Scientific - Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
FDA Device · Class II · 2025-09-17 · Boston Scientific - ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000
FDA Device · Class II · 2025-09-17 · Boston Scientific - Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011
FDA Device · Class II · 2025-09-17 · Boston Scientific - Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240,…
FDA Device · Class II · 2025-09-17 · Boston Scientific - Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011
FDA Device · Class II · 2025-09-17 · Boston Scientific - Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180
FDA Device · Class II · 2025-09-17 · Boston Scientific - WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to provide vascular and transseptal access for the family o…
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020
FDA Device · Class I · 2025-09-10 · Boston Scientific - WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010
FDA Device · Class I · 2025-09-10 · Boston Scientific - ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes
FDA Device · Class I · 2025-08-27 · Boston Scientific - ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT)
FDA Device · Class I · 2025-08-27 · Boston Scientific - RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes
FDA Device · Class I · 2025-08-27 · Boston Scientific - FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
FDA Device · Class II · 2025-08-20 · Boston Scientific - Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system
FDA Device · Class I · 2025-08-20 · Boston Scientific