Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 44-30-450-035 Material Number: M00573070 recall — FDA Z-0776-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Recall history in this database
Classification mix: Class II: 337, Class I: 121, Class III: 5.
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 44-20-450-035 Material Number: M00573050 recall — FDA Z-0774-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 39-30-260-025 Material Number: M00573100 recall — FDA Z-0771-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific HYDRATOME RX 44-30MM/450CM Material Number: M00583070 recall — FDA Z-0762-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 39-20-260-025 Material Number: M00573080 recall — FDA Z-0768-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 recall — FDA Z-0766-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific DREAMTOME 49-20MM/450CM Material Number: M00584020 recall — FDA Z-0756-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material recall — FDA Z-0751-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 49-30-450-035 Material Number: M00573030 recall — FDA Z-0779-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific JAGTOME RX 49-30-260-035 Material Number: M00573020 recall — FDA Z-0778-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceMar 23, 2022
Boston Scientific HYDRATOME RX 44-30MM/260CM Material Number: M00583050 recall — FDA Z-0761-2022
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceDec 22, 2021
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 recall — FDA Z-0381-2022
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Class IIFDA: TerminatedBoston Scientific Corporation
Medical DeviceDec 8, 2021
Boston Scientific HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of recall — FDA Z-0323-2022
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceDec 8, 2021
Boston Scientific HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of recall — FDA Z-0327-2022
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceDec 8, 2021
Boston Scientific HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of recall — FDA Z-0326-2022
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceDec 8, 2021
Boston Scientific HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of recall — FDA Z-0324-2022
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceDec 8, 2021
Boston Scientific HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of recall — FDA Z-0325-2022
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceAug 25, 2021
Boston Scientific TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE) recall — FDA Z-2327-2021
Potential for leaks and loosening at the patient catheter connection
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceAug 25, 2021
Boston Scientific TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE) recall — FDA Z-2328-2021
Potential for leaks and loosening at the patient catheter connection
Class IIFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 21, 2021
Boston Scientific INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 recall — FDA Z-2020-2021
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…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 21, 2021
Boston Scientific INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273 recall — FDA Z-2019-2021
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…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 21, 2021
Boston Scientific INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 recall — FDA Z-2016-2021
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…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 21, 2021
Boston Scientific ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 recall — FDA Z-2015-2021
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…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceJul 21, 2021
Boston Scientific INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) recall — FDA Z-2018-2021
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…
Class IFDA: OngoingBoston Scientific Corporation
Understanding this recall history
This page summarizes recall records in which the official source identifies Boston Scientific Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.