Boston Scientific Corporation 2024-11-20 Health critical FDA
Health · FDA · Recall #FDA-Z-0298-2025
Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100 Recall
Issued November 20, 2024 · Boston Scientific Corporation
In November 2024, Boston Scientific Corporation recalled the Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
What you should do
- 1 Stop using Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Boston Scientific Corporation
- Category
- Health
- Recall date
- November 20, 2024
- Units affected
- Not reported
- Sold at
- Worldwide
- Recall number
- FDA-Z-0298-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.