Boston Scientific NephroMax Kit recall: Foreign Material
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Why was Boston Scientific NephroMax Kit recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1. M0062101180, GTIN 08714729077589, Lot Numbers: 35275630, 35603649, 35618255, 35644223, 35768091; 2. M0062101600, GTIN 08714729834540, Lot Numbers: 35268077, 35294478, 35547681, 35576896, 35627459.
- Product
- Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 458 units
- Distribution
- Worldwide distribution.
- Recall date
- September 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)