Boston Scientific recalls AXIOS Stent and Electrocautery-Enhanced Delivery System 6mmx8mm UPN: M00553680 due to potential sheath detachment causing procedure delays. Affected units have specific lot numbers.
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Boston Scientific is recalling a specific stent delivery system because a part can detach during use, making the procedure last longer and requiring a replacement. This could cause delays in medical treatment.
The outer sheath's black tip can detach from the device during use. If it remains around the stent saddle, it prevents the stent from expanding properly, which may require the procedure to be repeated or exchanged.
Patients who have received the recalled stent delivery system for procedures. Those with the specific lot numbers are most at risk.
Check for the product name 'AXIOS Stent and Electrocautery-Enhanced Delivery System 6mmx8mm' with UPN: M00553680. Affected units have lot numbers 33457806, 33512838, or 34035520.
Identify the lot number on the device to see if it matches 33457806, 33512838, or 34035520.
The outer sheath's black tip can detach during use, preventing proper stent expansion and potentially prolonging the procedure.
Check the lot number on the device. If it matches 33457806, 33512838, or 34035520, contact Boston Scientific for guidance.
The recall is for potential procedure delays, not immediate injury risk. The hazard is low risk as it requires specific conditions to occur.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1028-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1028-2025 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.
