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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

238

Past Year

59

Class I (Serious)

0

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 221–238 of 238 recalls

Boston Scientific Corporation: IceSeed" 1.5 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: IceRod" 1.5 MRI Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: IceRod" 1.5 i-Thaw" Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

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Boston Scientific Corporation: IceSeed" 1.5 MRI 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: IceRod" 1.5 PLUS Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: IceRod" 1.5 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: IcePearl" 2.1 CX Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: IceSphere" 1.5 90 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Three IcePearl" 2.1 CX Prostate Cryoablation Kit

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: IceSphere" 1.5 Cryoablation Needle

Complaint trend regarding needle shaft gas leaks.

FDANov 18, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Contour VL Variable Length Ureteral Stent, UPN M006180155...

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

FDANov 16, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSoni...

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.

FDANov 3, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: AMS 700 MS Pump with and without InhibiZone, sold as indi...

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.

FDASep 24, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Hurricane RX Biliary Balloon Dilatation Catheter Catalog ...

RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.

FDASep 16, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Captivator Polypectomy Snare, Single-Use Polypectomy Snar...

Laceration Risk

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.

FDAJul 6, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Captiflex Snares, Single-Use Polypectomy Snare consists o...

Laceration Risk

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.

FDAJul 6, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Imager II 5F Angiographic Catheters, 5 units per package.

Potential for tip detachment of Imager II 5F Angiographic Catheters

FDAFeb 11, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Subcutaneous Implantable Cardioverter Defibrillator (S-IC...

Potential need for device replacement - Elective Replacement Indicator (ERI) or End of Life (EOL) - earlier than expected due to compromised performance of an electrical component causing accelerated battery depletion.

FDAAug 21, 2019Nationwide• Boston Scientific Corporation