Boston Scientific recalls NephroMax Kit (UPNs M0062101180, M0062101600) due to foreign material particles migrating into balloon catheters during use. Affected units include specific lot numbers and GTINs.
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.
Boston Scientific is recalling NephroMax Kits with specific material numbers and lot numbers because foreign particles can migrate into balloon catheters during use. This could lead to complications in urological procedures.
Foreign material particles can migrate from the Encore 26 Inflation Device into the balloon dilatation catheter during use. This migration could cause complications during urological procedures where pressure is monitored and adjusted.
Urology patients and healthcare providers using the recalled NephroMax Kits for balloon dilation procedures. Those with the specific material numbers and lot numbers are most at risk.
Check for material numbers M0062101180 or M0062101600. The kits include specific lot numbers and GTINs listed in the recall notice.
Identify the material numbers (M0062101180 or M0062101600) and lot numbers listed in the recall notice.
Foreign material particles can migrate from the Encore 26 Inflation Device into the balloon dilatation catheter during use, potentially causing complications in urological procedures.
Lot numbers 35275630, 35603649, 35618255, 35644223, 35768091 for material number M0062101180 and 35268077, 35294478, 35547681, 35576896, 35627459 for material number M0062101600.
The recall does not specify a stop-use instruction; affected users should check product details and follow the provided action steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2535-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2535-2025 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
