Boston Scientific recalls AXIOS Stent 8mmx8mm UPN M00553690 due to risk of sheath tip detaching, preventing stent expansion and prolonging procedures. Affected units include 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 AXIOS Stent and Electrocautery-Enhanced Delivery System 8mmx8mm models with UPN M00553690. The sheath tip may detach during use, preventing proper stent expansion and requiring a longer procedure to replace the device.
The outer sheath's black tip can detach from the device during use. If it remains around the stent saddle, it blocks proper stent expansion, requiring a longer procedure to exchange the device for a new one.
Patients undergoing stent procedures who own the recalled model are affected. Those with the specific lot numbers listed are most at risk.
Check for the UPN code M00553690 on the device. Affected units include lot numbers 33419782, 33477824, 34116467, 33419783, and 33511487.
Identify the UPN code and lot numbers to confirm if your device is recalled.
The recall is for potential sheath tip detachment that could prolong procedures, but it does not cause immediate injury.
Check for UPN M00553690 and lot numbers 33419782, 33477824, 34116467, 33419783, or 33511487.
The recall does not specify a remedy, so contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1029-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1029-2025 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.
