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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
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
Cardiac Devices·1,086 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Cardiac Devices·2,245 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Cardiac Devices·4,990 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
Cardiac Devices·326 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
Cardiac Devices·828 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Cardiac Devices·8,475 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Cardiac Devices·3,777 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
Cardiac Devices·2,184 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
EMBLEM S-ICD Pulse Generator Model A209; Subcutaneous Implantable Cardioverter Defibrillator
Medical Implants·3,856 affected·Jul 11, 2023
CriticalFDA
Boston Scientific Corporation
Flexiva Pulse 242 TracTip Single-Use Laser Fibers -intended to be used as a device that transmits Ho:YAG laser energy from cleared laser ...
Medical Devices·1,245 affected·May 25, 2023
CriticalFDA
Boston Scientific Corporation
Flexiva Pulse 242 TracTip Single-Use Laser Fibers - intended to be used as a device that transmits Ho:YAG laser energy from cleared laser...
Medical Devices·339 affected·May 25, 2023
CriticalFDA
Boston Scientific Corporation
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy (B...
Medical Devices·205 affected·May 25, 2023
CriticalFDA
Boston Scientific Corporation
Flexiva Pulse 242 Single-Use Laser Fibers-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles ...
Medical Devices·66 affected·May 25, 2023
CriticalFDA
Boston Scientific Corporation
Flexiva Pulse ID-intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy Si...
Medical Devices·112 affected·May 25, 2023
High RiskFDA
Boston Scientific Corporation
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Medical Devices·1,300 affected·Apr 5, 2023
High RiskFDA
Boston Scientific Corporation
WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
Medical Devices·10,833 affected·Apr 5, 2023
High RiskFDA
Boston Scientific Corporation
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to perform pa...
Surgical Devices·6,635 affected·Feb 2, 2023
High RiskFDA
Boston Scientific Corporation
LATITUDE NXT Remote Patient Management System, LATITUDE NXT System Server Software Model 6460.
Medical Devices·1,531 affected·Feb 2, 2023
High RiskFDA
Boston Scientific Corporation
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Medical Devices·16 affected·Oct 13, 2022
High RiskFDA
Boston Scientific Corporation
EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.
Medical Implants·7 affected·Sep 30, 2022
High RiskFDA
Boston Scientific Corporation
EMBLEM MRI S-ICD, Subcutaneous Implantable Defibrillator, Model A219, sterile.
Medical Implants·142 affected·Sep 30, 2022
High RiskFDA
Boston Scientific Corporation
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Surgical Devices·184 affected·Aug 9, 2022
High RiskFDA
Boston Scientific Corporation
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse ge...
Medical Implants·17,172 affected·Jul 7, 2022
High RiskFDA
Boston Scientific Corporation
EkoSonic Kit 106cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They ...
Medical Devices·10 affected·May 25, 2022
High RiskFDA
Boston Scientific Corporation
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Medical Devices·433 affected·Mar 8, 2022
High RiskFDA
Boston Scientific Corporation
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Medical Devices·488 affected·Mar 8, 2022
High RiskFDA
Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intend...
Medical Devices·6,946 affected·Mar 3, 2022
High RiskFDA
Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video duodenoscope intend...
Medical Devices·1,486 affected·Mar 3, 2022
High RiskFDA
Boston Scientific Corporation
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostat...
Medical Devices·61,852 affected·Feb 24, 2022
High RiskFDA
Boston Scientific Corporation
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiot...
Medical Devices·23,368 affected·Feb 24, 2022
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Medical Devices·254 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 44-20-260-035 Material Number: M00573040
Medical Devices·3,578 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Medical Devices·112 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 44-30MM/260CM Material Number: M00584050
Medical Devices·12,067 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 39-30-260-025 Material Number: M00573100
Medical Devices·1,447 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 39-20-450-025 Material Number: M00573090
Medical Devices·367 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Medical Devices·7,115 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 49-20MM/260CM Material Number: M00584000
Medical Devices·982 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 49-30MM/450CM Material Number: M00584030
Medical Devices·32 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME RX 49-20-260-035 Material Number: M00573000
Medical Devices·101 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 44-30MM/450CM Material Number: M00584070
Medical Devices·142 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Medical Devices·3,330 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
Medical Devices·500 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 44-20MM/260CM Material Number: M00583040
Medical Devices·7,695 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
DREAMTOME 49-30MM/260CM Material Number: M00584010
Medical Devices·472 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
Medical Devices·1,811 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
HYDRATOME RX 49-30MM/260CM Material Number: M00583010
Medical Devices·0 affected·Dec 22, 2021
High RiskFDA
Boston Scientific Corporation
RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M00575400 M0057544...
Medical Devices·0 affected·Dec 22, 2021