Boston Scientific recalls
Boston Scientific appears in 660 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.
- 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 - 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 Used for the per…
FDA Device · Class II · 2025-07-16 · Boston Scientific - VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart
FDA Device · Class II · 2025-07-16 · Boston Scientific - VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1)…
FDA Device · Class II · 2025-07-16 · Boston Scientific - VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-…
FDA Device · Class II · 2025-07-16 · Boston Scientific - IceSeed 1.5 CX NEEDLE US, Cryoablation Needle, REF H7493967433170
FDA Device · Class II · 2025-05-07 · Boston Scientific - IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100
FDA Device · Class II · 2025-05-07 · Boston Scientific - IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170
FDA Device · Class II · 2025-05-07 · Boston Scientific - IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100
FDA Device · Class II · 2025-05-07 · Boston Scientific - AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
FDA Device · Class II · 2025-02-05 · Boston Scientific - AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
FDA Device · Class II · 2025-02-05 · Boston Scientific - AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650
FDA Device · Class II · 2025-02-05 · Boston Scientific - AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690
FDA Device · Class II · 2025-02-05 · Boston Scientific - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560
FDA Device · Class II · 2025-02-05 · Boston Scientific - AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660
FDA Device · Class II · 2025-02-05 · Boston Scientific - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530
FDA Device · Class II · 2025-02-05 · Boston Scientific - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550
FDA Device · Class II · 2025-02-05 · Boston Scientific - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570
FDA Device · Class II · 2025-02-05 · Boston Scientific - AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750
FDA Device · Class II · 2025-02-05 · Boston Scientific - AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640
FDA Device · Class II · 2025-02-05 · Boston Scientific - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520
FDA Device · Class II · 2025-02-05 · Boston Scientific - AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
FDA Device · Class II · 2025-02-05 · Boston Scientific - HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
FDA Device · Class II · 2025-02-05 · Boston Scientific - VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
FDA Device · Class I · 2025-01-22 · Boston Scientific - ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
FDA Device · Class I · 2025-01-22 · Boston Scientific - PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MR…
FDA Device · Class I · 2025-01-22 · Boston Scientific - ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
FDA Device · Class I · 2025-01-22 · Boston Scientific - VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
FDA Device · Class I · 2025-01-22 · Boston Scientific - ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
FDA Device · Class I · 2025-01-22 · Boston Scientific - AMS Artificial Urinary Sphincter Control Pump
FDA Device · Class II · 2024-12-04 · Boston Scientific - AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
FDA Device · Class II · 2024-12-04 · Boston Scientific - Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
FDA Device · Class I · 2024-11-20 · Boston Scientific - Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
FDA Device · Class I · 2024-11-20 · Boston Scientific - Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
FDA Device · Class I · 2024-11-20 · Boston Scientific - Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000
FDA Device · Class I · 2024-11-20 · Boston Scientific - Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000
FDA Device · Class I · 2024-11-20 · Boston Scientific - Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
FDA Device · Class I · 2024-11-20 · Boston Scientific - Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
FDA Device · Class I · 2024-11-20 · Boston Scientific - Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor applic…
FDA Device · Class II · 2024-10-30 · Boston Scientific - Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US
FDA Device · Class II · 2024-10-23 · Boston Scientific - Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN
FDA Device · Class II · 2024-10-23 · Boston Scientific - Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US
FDA Device · Class II · 2024-10-23 · Boston Scientific - Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO
FDA Device · Class II · 2024-10-23 · Boston Scientific - Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN
FDA Device · Class II · 2024-10-23 · Boston Scientific - Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW
FDA Device · Class II · 2024-10-23 · Boston Scientific - Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US
FDA Device · Class II · 2024-10-23 · Boston Scientific