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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.
December 30, 2020Medical DevicesFDA
Boston Scientific Corporation recalls IceRod" 1.5 i-Thaw" Cryoablation Needle
Hazard: Complaint trend regarding needle shaft gas leaks.
December 30, 2020Medical DevicesFDA
Boston Scientific Corporation recalls IceSphere" 1.5 CX 90¿ Cryoablation Needle
Hazard: Complaint trend regarding needle shaft gas leaks.
December 30, 2020Medical DevicesFDA
Boston Scientific Corporation recalls IceRod" 1.5 CX 90¿ Cryoablation Needle¿
Hazard: Complaint trend regarding needle shaft gas leaks.
December 30, 2020Medical DevicesFDA
Boston Scientific Corporation recalls IcePearl" 2.1 CX L 90¿ Cryoablation Needle
Hazard: Complaint trend regarding needle shaft gas leaks.
December 30, 2020Medical DevicesFDA
Boston Scientific Corporation recalls IcePearl" 2.1 CX Cryoablation Needle
Hazard: Complaint trend regarding needle shaft gas leaks.
December 30, 2020Medical DevicesFDA
Boston Scientific Corporation recalls IcePearl" 2.1 CX 90¿ Cryoablation Needle
Hazard: Complaint trend regarding needle shaft gas leaks.
December 30, 2020Medical DevicesFDA
Boston Scientific Corporation recalls IceFORCE" 2.1 CX L 90¿ Cryoablation Needle
Hazard: Complaint trend regarding needle shaft gas leaks.
December 30, 2020Medical DevicesFDA
Boston Scientific Corporation recalls IceFORCE" 2.1 CX Cryoablation Needle
Hazard: Complaint trend regarding needle shaft gas leaks.
December 30, 2020Medical DevicesFDA
Boston Scientific Corporation recalls IceFORCE" 2.1 CX 90¿ Cryoablation Needle
Hazard: Complaint trend regarding needle shaft gas leaks.
December 23, 2020Medical DevicesFDA
Boston Scientific Corporation recalls EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use
Hazard: This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.
November 18, 2020Medical DevicesFDA
Boston Scientific Corporation recalls AMS 700 MS Pump with and without InhibiZone, sold as individual units and also pre-connected to AMS 700 cylinders. Infla
Hazard: The recalling firm has observed an increase in complaints of problems encountered during the initial activation of the device in which the patient and/or the physician is unable or has difficulty activating the pump in order to achieve cylinder inflation.
November 11, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Model 3300 LATITUDE Programming System with installed Model 3892 ALTRUA, INSIGNIA I, NEXUS I Software Support Applicatio
Hazard: There is potential when a user changes an EGM trace channel with a Manual Pace Threshold test in progress that the newly modified trace channel may change to a flat line.
November 4, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Visual-ICE MRI Cryoablation System Mobile Connection Panel (Visual-ICE MRI MCP) - Product Usage: The system is computer-
Hazard: Incorrectly installed base.
November 4, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930;
Hazard: RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.
October 28, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 mm) X 105 cm Expiration Date June 8th 2021 - July 22nd 2021 Ma
Hazard: Opticross 35 Peripheral Imaging Catheter is being recalled because the incremental telescoping length markings near the proximal end of the catheter shaft can flake off when the device is manipulated. No patient harm has been reported to date. The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most server health consequence that is reasonably expected to occur if a catheter with this potential issue is used is embolization which would result of the flaking marks advance while flushing the catheter. All recalled devices should be returned to Boston Scientific.
September 23, 2020Medical DevicesFDA
Boston Scientific Corporation recalls WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for
Hazard: Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
August 12, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be exte
Hazard: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
August 12, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Captiflex Snares, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and ret
Hazard: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
August 12, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be exte
Hazard: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
August 12, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be exte
Hazard: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
August 12, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be exte
Hazard: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
August 12, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be exte
Hazard: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
August 12, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be exte
Hazard: BSC has noted a potential inability to cut and remove polyps for these lots/batches. potential consequences related to the snares not performing as intended would be a prolonged procedure duration, tissue damage and/or self-limited bleeding. The most severe potential injury would include immediate or delayed hemorrhage and/or perforation requiring intervention up to and including open surgery; the likelihood of these severe injuries occurring is remote and, to date, have not been reported as a complaint. The potential inability to cut may also lead to inadequate removal of target tissue.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablat
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablat
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil M
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Gali
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cr
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cr
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.
July 29, 2020Medical DevicesFDA
Boston Scientific Corporation recalls Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoab
Hazard: The needle surface deteriorated due to unexpected electrolysis during procedure.