Recall of Boston Scientific UroMax Ultra Kit with specific material numbers and lot numbers due to risk of foreign material particles migrating into balloon catheters during use.
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 certain UroMax Ultra Kits because foreign material particles can migrate from the inflation device into balloon catheters during use. This could potentially cause complications during medical procedures.
The Encore 26 Inflation Device in the kit can allow foreign material particles to migrate into balloon dilatation catheters during medical procedures. This migration could lead to complications if the particles enter the patient's body during treatment.
Urology patients using the recalled UroMax Ultra Kits with specific material numbers and lot numbers. Healthcare providers who use these kits are most at risk.
Check for material numbers (UPN) starting with M0062251200 through M0062251370 and specific lot numbers listed in the recall notice. The kits are used in urology procedures.
Review the material numbers (UPN) and lot numbers listed in the recall notice to confirm if your kit is affected.
Foreign material particles can migrate from the Encore 26 Inflation Device into balloon dilatation catheters during use, potentially causing complications.
Check the material numbers (UPN) and lot numbers listed in the recall notice, which include specific codes like M0062251200 through M0062251370 and associated lot numbers.
No action is required if your kit's material numbers and lot numbers are not on the recall list.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2536-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2536-2025 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.
