Boston Scientific NephroMax Kit recalled for foreign material contamination
Boston Scientific is recalling the NephroMax Kit because foreign material particles could migrate from the inflation device into balloon dilation catheters during use. Worldwide distribution of 458 units.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II designation for a medical device with contamination risk from foreign material particles. No reported injuries or illnesses, qualifying as a risk-of-harm product where injury has not yet been reported per the rubric.
Plain-English summary
Boston Scientific is recalling the NephroMax Kit, which includes the Encore 26 Inflation Device used in urology procedures. This 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 foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilation catheter during use.
The recall affects 458 units of NephroMax Kit with material numbers M0062101180 and M0062101600 and their associated lot numbers. These units have been distributed worldwide.
The recalled product
- Product
- Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
- Manufacturer
- Boston Scientific Corporation
- Hazard
- foreign-material-contamination
- particle-migration
- product-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 1. M0062101180
- GTIN 08714729077589
- Lot Numbers: 35275630
- 35603649
- 35618255
- 35644223
- 35768091
- 2. M0062101600
- GTIN 08714729834540
- Lot Numbers: 35268077
- 35294478
- 35547681
- 35576896
- 35627459.
Distribution
Distribution scope not specified by the agency.
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