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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
JAGTOME RX 44-30-260-035 Material Number: M00573060
Medical Devices·2,209 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Medical Devices·7 affected·Nov 8, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M0...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M0054...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005...
Medical Devices·0 affected·Oct 21, 2021
High RiskFDA
Boston Scientific Corporation
TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Medical Devices·4,980 affected·Jul 23, 2021
High RiskFDA
Boston Scientific Corporation
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Cardiac Devices·70,074 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Cardiac Devices·6,377 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Medical Devices·3,634 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Cardiac Devices·2,952 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Medical Devices·1,707 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
Cardiac Devices·40,224 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usage: intended for use as a bridging material for sacrocolposu...
Medical Devices·8,524 affected·Apr 15, 2021
High RiskFDA
Boston Scientific Corporation
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and...
Medical Devices·4,549 affected·Apr 15, 2021
CriticalFDA
Boston Scientific Corporation
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Medical Implants·550 affected·Apr 12, 2021
High RiskFDA
Boston Scientific Corporation
The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consi...
Medical Implants·23 affected·Mar 26, 2021
RecallFDA
Boston Scientific Corporation
EXALT Controller - Product Usage: intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video obse...
Medical Devices·3 affected·Mar 16, 2021
High RiskFDA
Boston Scientific Corporation
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in ...
Surgical Devices·52 affected·Mar 5, 2021
High RiskFDA
Boston Scientific Corporation
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box...
Medical Devices·335,788 affected·Jan 19, 2021
High RiskFDA
Boston Scientific Corporation
Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares Outer box UPN, Inner pouch UPN: M00560311 (Box 5), M005603...
Medical Devices·335,788 affected·Jan 19, 2021
High RiskFDA
Boston Scientific Corporation
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Medical Devices·7,093 affected·Dec 2, 2020
CriticalFDA
Boston Scientific Corporation
EMBLEM S-ICD Model A209
Medical Devices·1,953 affected·Dec 2, 2020
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
Medical Devices·11,296 affected·Dec 2, 2020
CriticalFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD Model A219
Medical Devices·872 affected·Dec 2, 2020
High RiskFDA
Boston Scientific Corporation
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for ...
Medical Implants·78 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantati...
Medical Implants·38 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for ...
Medical Implants·61 affected·Dec 1, 2020
High RiskFDA
Boston Scientific Corporation
IceSeed" 1.5 Cryoablation Needle
Medical Devices·152 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IcePearl" 2.1 CX 90¿ Cryoablation Needle
Medical Devices·8,453 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceRod" 1.5 CX 90¿ Cryoablation Needle¿
Medical Devices·18,731 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
Five IceSphere" Prostate Cryoablation Kit
Medical Devices·419 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IcePearl" 2.1 CX Cryoablation Needle
Medical Devices·86 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceRod" 1.5 i-Thaw" Cryoablation Needle
Medical Devices·262 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceSeed" 1.5 90¿ Cryoablation Needle
Medical Devices·788 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceSeed" 1.5 MRI Cryoablation Needle
Medical Devices·627 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceSphere" 1.5 CX 90¿ Cryoablation Needle
Medical Devices·6,363 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceSphere" 1.5 Cryoablation Needle
Medical Devices·39 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceSphere" 1.5 S 90¿ Cryoablation Needle
Medical Devices·729 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceFORCE" 2.1 CX 90¿ Cryoablation Needle
Medical Devices·22,289 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceRod" 1.5 PLUS 90¿ Cryoablation Needle
Medical Devices·4,645 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
Five IceRod" i-Thaw" Prostate Cryoablation Kit
Medical Devices·178 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
Medical Devices·525 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
IceSeed" Prostate Cryoablation Kit
Medical Devices·52 affected·Nov 18, 2020
High RiskFDA
Boston Scientific Corporation
Three IcePearl" 2.1 CX Prostate Cryoablation Kit
Medical Devices·117 affected·Nov 18, 2020