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Boston Scientific Recalls
651 recalls on record · June 27, 2012 to August 12, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 25, 2022Medical DevicesFDA
Boston Scientific Corporation recalls EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video du
Hazard: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
May 25, 2022Medical DevicesFDA
Boston Scientific Corporation recalls EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 Intended Use: sterile, single-use, flexible video du
Hazard: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
May 4, 2022Medical DevicesFDA
Boston Scientific Corporation recalls SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prost
Hazard: Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
May 4, 2022Medical DevicesFDA
Boston Scientific Corporation recalls SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away
Hazard: Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.
April 20, 2022Medical DevicesFDA
Boston Scientific Corporation recalls ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Extra Support
Hazard: Pouch seals may be open, compromising sterility.
April 20, 2022Medical DevicesFDA
Boston Scientific Corporation recalls ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Hazard: Pouch seals may be open, compromising sterility.
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls RX CHOLANGIOGRAM KIT - SINGLE Material Number: M00575240 M00575240 M00575280 M00575320 M00575360 M00575380 M0
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 49-30-450-035 Material Number: M00573030
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 49-30-260-035 Material Number: M00573020
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 49-20-260-035 Material Number: M00573000
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 44-30-450-035 Material Number: M00573070
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 44-30-260-035 Material Number: M00573060
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 44-20-450-035 Material Number: M00573050
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 44-20-260-035 Material Number: M00573040
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 39-30-450-025 Material Number: M00573110
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 39-30-260-025 Material Number: M00573100
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 39-30-260-025 Material Number: M00573100
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 39-20-450-025 Material Number: M00573090
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME RX 39-20-260-025 Material Number: M00573080
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls HYDRATOME RX 49-30MM/260CM Material Number: M00583010
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls HYDRATOME RX 49-20MM/260CM Material Number: M00583000
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls HYDRATOME RX 44-30MM/450CM Material Number: M00583070
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls HYDRATOME RX 44-30MM/260CM Material Number: M00583050
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls HYDRATOME RX 44-20MM/450CM Material Number: M00583060
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls HYDRATOME RX 44-20MM/260CM Material Number: M00583040
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls DREAMTOME 49-30MM/450CM Material Number: M00584030
Hazard: Sterility of device is compromised due to a sterile barrier breach