Z-2535-2025 Class II Ongoing
FDA device recall Z-2535-2025 was initiated by Boston Scientific Corporation on August 5, 2025 and is designated Class II. Reason for recall: 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, f… The recall status is ongoing. Affected quantity: 458 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 17, 2025
- Initiation Date
- August 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 458 units
Product Description
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Reason for Recall
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.
Distribution Pattern
Worldwide distribution.
Code Information
1. M0062101180, GTIN 08714729077589, Lot Numbers: 35275630, 35603649, 35618255, 35644223, 35768091; 2. M0062101600, GTIN 08714729834540, Lot Numbers: 35268077, 35294478, 35547681, 35576896, 35627459.