Boston Scientific Corporation 2025-09-17 Health serious FDA
Health · FDA · Recall #FDA-Z-2535-2025
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; … Recall
Issued September 17, 2025 · Boston Scientific Corporation
In September 2025, Boston Scientific Corporation recalled the Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; …, a serious 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
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
What you should do
- 1 Stop using Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; … 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
- September 17, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution.
- Recall number
- FDA-Z-2535-2025
- 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 691st Health recall we've logged in 2025.