FDA Enforcement
Class II
Ongoing
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Recall: Z-2535-2025
·
Reported September 17, 2025
Enforcement
- Recall Number
- Z-2535-2025
- Event ID
- 97396
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Boston Scientific Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 17, 2025
- Initiation Date
- August 5, 2025
- Classification Date
- September 5, 2025
- Address
- 1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States
Description
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Reason
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.
Code Info
1. M0062101180, GTIN 08714729077589, Lot Numbers: 35275630, 35603649, 35618255, 35644223, 35768091; 2. M0062101600, GTIN 08714729834540, Lot Numbers: 35268077, 35294478, 35547681, 35576896, 35627459.
Distribution
Worldwide distribution.
Quantity
458 units