Boston Scientific Corporation
Saint Paul, MN
This page shows every FDA and USDA recall linked to Boston Scientific Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
126
Total Recalls
2015
First Recall
2025
Most Recent
Model Number S702, ALTRUA 2 DR SL Pacemaker
Oct 10, 2025
· Device
Active
Model Number U225 VISIONIST CRT-P EL
Oct 10, 2025
· Device
Active
ACCOLADE SR SL (Model L300)
Oct 10, 2025
· Device
Active
Model Number L221 PROPONENT DR EL Pacemaker
Oct 10, 2025
· Device
Active
PROPONENT SR SL (Model L200)
Oct 10, 2025
· Device
Active
Model Number L121 ESSENTIO DR EL Pacemaker
Oct 10, 2025
· Device
Active
Model Number U128, VALITUDE CRT-P EL MRI
Oct 10, 2025
· Device
Active
ACCOLADE DR SL (Model L301)
Oct 10, 2025
· Device
Active
Model Number L111, ESSENTIO DR SL MRI Pacemaker
Oct 10, 2025
· Device
Active
PROPONENT DR SL (Model L201)
Oct 10, 2025
· Device
Active
Model Number L131, ESSENTIO DR EL MRI Pacemaker
Oct 10, 2025
· Device
Active
Model Number L100, ESSENTIO SR SL Pacemaker
Oct 10, 2025
· Device
Active
Model Number U226, VISIONIST CRT-P EL
Oct 10, 2025
· Device
Active
Model Number U125, VALITUDE CRT-P EL
Oct 10, 2025
· Device
Active
Model Number S722, ALTRUA 2 DR EL Pacemaker
Oct 10, 2025
· Device
Active
Model Number L110, ESSENTIO SR SL MRI Pacemaker
Oct 10, 2025
· Device
Active
ACCOLADE SR SL MRI (Model L310)
Oct 10, 2025
· Device
Active
ACCOLADE DR SL MRI (Model L311)
Oct 10, 2025
· Device
Active
Model Number L211 PROPONENT DR SL MRI Pacemaker
Oct 10, 2025
· Device
Active
Model Number L210 PROPONENT SR SL Pacemaker
Oct 10, 2025
· Device
Active
Model Number L101, ESSENTIO DR SL Pacemaker
Oct 10, 2025
· Device
Active
Model Number S701 ALTRUA 2 SR SL Pacemaker
Oct 10, 2025
· Device
Active
Model Number U228, VISIONIST CRT-P EL MRI
Oct 10, 2025
· Device
Active
Model Number L231, PROPONENT DR EL MRI Pacemaker
Oct 10, 2025
· Device
Active
ACCOLADE DR EL (Model L321)
Oct 10, 2025
· Device
Active
ACCOLADE DR EL MRI (Model L331)
Oct 10, 2025
· Device
Active
Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Oct 10, 2025
· Device
Active
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electr...
Aug 20, 2025
· Device
Active
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Mode...
Aug 20, 2025
· Device
Active
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrod...
Aug 20, 2025
· Device
Active
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Aug 8, 2025
· Device
Active
VersaCross Transseptal Sheath Kit (VXS)
Product Description/IDs
VXS0201
VXS 63CM/45DEG/D0 SHEATH
VXS2112
VERS...
Jul 10, 2025
· Device
Active
Torflex Transseptal Guiding Sheath Kit (TFK-M)
TF85-32-63-45
TORFLEX 8.5F 63CM 45DEG
TF85-32-63-55
TORFLEX 8...
Jul 10, 2025
· Device
Active
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart.
Product ID VXW0002...
Jul 10, 2025
· Device
Active
VersaCross Access Solution (VXSK),
Product Description and ID:
VXSK (180J RF WIRE 63CM/45DEG/D0)
VXSK0101
VXS...
Jul 10, 2025
· Device
Active
VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)
Jan 10, 2025
· Device
Active
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Jan 10, 2025
· Device
Active
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (...
Jan 10, 2025
· Device
Active
ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)
Jan 10, 2025
· Device
Active
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (...
Jan 10, 2025
· Device
Active
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI...
Jan 10, 2025
· Device
Active
Boston Scientific SMARTFREEZE CRYO CONSOLE:
Console: Material Number M004CRBS4000; CONSOLE REFURB: Materia...
Nov 12, 2024
· Device
Active
Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060
Nov 12, 2024
· Device
Active
Boston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010
Nov 12, 2024
· Device
Active
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Nov 12, 2024
· Device
Active
Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110
Nov 12, 2024
· Device
Active
Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.
Nov 12, 2024
· Device
Active
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100
Nov 12, 2024
· Device
Active
Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2...
Oct 25, 2024
· Device
Active
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Mar 26, 2024
· Device
Active