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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

Class I (Serious)

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 241–260 of 506 recalls

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: Lotus Edge Valve System, Transcatheter Aortic Valve Prost...

Laceration Risk

Failure to execute the visual inspection correctly prior to locking the valve during the deployment process can lead to the inability to release the delivery system.

FDANov 17, 2020AL, AZ, AR +35 more• 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.

1...11 121314 15...26

Page 13 of 26Next

FDA

Nov 16, 2020

Nationwide

• Boston Scientific Corporation

Boston Scientific Corporation: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Componen...

There is potential for fractures which results in the inability to delivery therapy.

FDANov 13, 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: Visual-ICE MRI Cryoablation System Mobile Connection Pane...

Incorrectly installed base.

FDASep 22, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Model 3300 LATITUDE Programming System with installed Mod...

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.

FDASep 22, 2020AR, FL, IL +2 more• 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: Opticross 35 15 MHz Peripheral Imaging Catheter 8F (2.74 ...

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.

FDAAug 24, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: WallFlexTM Biliary RX Fully Covered Stent System RMV (10m...

Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device

FDAAug 7, 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: Captivator Polypectomy Snare, Single-Use Polypectomy Snar...

Laceration Risk

FDAJul 6, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Ablation Galil Technology, Three IceFORCE 2.1 CX Prostat...

The needle surface deteriorated due to unexpected electrolysis during procedure.

FDAJun 4, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryo...

The needle surface deteriorated due to unexpected electrolysis during procedure.

FDAJun 4, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablatio...

The needle surface deteriorated due to unexpected electrolysis during procedure.

FDAJun 4, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: MoXy Laser Fiber, Material Number 0010-2400 - Product Usa...

To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.

FDAMar 30, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific, Implantable Cardioverter Defibrillator...

Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.

FDAFeb 12, 2020Nationwide• Boston Scientific Corporation

Boston Scientific Corporation: Boston Scientific, LATITUDE Programming System, Model 330...

FDAFeb 12, 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