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Boston Scientific Corporation

Boston Scientific Corporation Recalls

All product recalls associated with Boston Scientific Corporation.

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Recall Summary

Total Recalls

506

Past Year

59

Class I (Serious)

3

Most Recent

Sep 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 161–180 of 506 recalls

Boston Scientific Corporation: JAGTOME RX 49-20-260-035 Material Number: M00573000

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/4...

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: DREAMTOME 49-20MM/450CM Material Number: M00584020

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide

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• Boston Scientific Corporation

Boston Scientific Corporation: RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575...

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00...

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: HYDRATOME RX 44-20MM/260CM Material Number: M00583040

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: HYDRATOME RX 49-20MM/260CM Material Number: M00583000

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: DREAMTOME 49-30MM/450CM Material Number: M00584030

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: HYDRATOME RX 44-20MM/450CM Material Number: M00583060

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: DREAMTOME 49-30MM/260CM Material Number: M00584010

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: JAGTOME RX 44-20-450-035 Material Number: M00573050

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: JAGTOME RX 39-20-450-025 Material Number: M00573090

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: JAGTOME RX 39-30-450-025 Material Number: M00573110

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: JAGTOME RX 44-30-450-035 Material Number: M00573070

Sterility of device is compromised due to a sterile barrier breach

FDADec 22, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific ROTAPRO, Rotational Atherectomy System ...

Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.

FDANov 8, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dila...

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

FDAOct 21, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: TheraSphere Administration Set, REF OTT-SPE-FP-226 (99022...

Potential for leaks and loosening at the patient catheter connection

FDAJul 23, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L...

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

FDAJun 3, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.

FDAJun 3, 2021Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J0...

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population

FDAJun 3, 2021Nationwide• Boston Scientific Corporation