FDA-Device2025-09-17Class II
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Boston Scientific Corporation
Hazard
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.
Sold states
Worldwide distribution.
Affected count
458 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2535-2025Don't want to check this manually?
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