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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.
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls DREAMTOME 49-30MM/260CM Material Number: M00584010
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls DREAMTOME 49-20MM/450CM Material Number: M00584020
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls DREAMTOME 49-20MM/260CM Material Number: M00584000
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls DREAMTOME 44-30MM/450CM Material Number: M00584070
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls DREAMTOME 44-30MM/260CM Material Number: M00584050
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
Hazard: Sterility of device is compromised due to a sterile barrier breach
March 23, 2022Medical DevicesFDA
Boston Scientific Corporation recalls Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
Hazard: Sterility of device is compromised due to a sterile barrier breach
December 22, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Hazard: Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
December 8, 2021Medical DevicesFDA
Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of
Hazard: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
December 8, 2021Medical DevicesFDA
Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of
Hazard: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
December 8, 2021Medical DevicesFDA
Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of
Hazard: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
December 8, 2021Medical DevicesFDA
Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of
Hazard: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
December 8, 2021Medical DevicesFDA
Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter
Hazard: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
December 8, 2021Medical DevicesFDA
Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of O
Hazard: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
December 8, 2021Medical DevicesFDA
Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of O
Hazard: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
December 8, 2021Medical DevicesFDA
Boston Scientific Corporation recalls HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of O
Hazard: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
August 25, 2021Medical DevicesFDA
Boston Scientific Corporation recalls TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)
Hazard: Potential for leaks and loosening at the patient catheter connection
August 25, 2021Medical DevicesFDA
Boston Scientific Corporation recalls TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)
Hazard: Potential for leaks and loosening at the patient catheter connection
July 21, 2021Medical DevicesFDA
Boston Scientific Corporation recalls INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Hazard: 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
July 21, 2021Medical DevicesFDA
Boston Scientific Corporation recalls INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Hazard: 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
July 21, 2021Medical DevicesFDA
Boston Scientific Corporation recalls INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
Hazard: 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
July 21, 2021Medical DevicesFDA
Boston Scientific Corporation recalls VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (
Hazard: 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
July 21, 2021Medical DevicesFDA
Boston Scientific Corporation recalls INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187
Hazard: 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
July 21, 2021Medical DevicesFDA
Boston Scientific Corporation recalls ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087
Hazard: 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
July 14, 2021Medical DevicesFDA
Boston Scientific Corporation recalls VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
Hazard: 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.
July 14, 2021Medical DevicesFDA
Boston Scientific Corporation recalls VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Hazard: 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.
July 14, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Hazard: 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.
July 14, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Hazard: 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.
July 14, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
Hazard: 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.
July 14, 2021Medical DevicesFDA
Boston Scientific Corporation recalls Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Hazard: 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.