Boston Scientific recalls AXIOS Stent 10mmx10mm models with specific lot numbers due to risk of outer sheath tip detaching during procedure, potentially prolonging surgery. Affected units may need replacement.
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 certain AXIOS Stent and Electrocautery-Enhanced Delivery Systems because the outer sheath tip can detach during use. This may cause the stent to not expand properly, leading to longer surgery times and requiring device exchange.
The outer sheath's black tip can detach from the device during use. If it remains around the stent saddle, the stent may not expand properly, causing the procedure to take longer and potentially requiring a device exchange.
Medical professionals using the AXIOS Stent system during procedures are most at risk. Patients undergoing stent placement may experience longer surgeries if the device fails to expand correctly.
Check for the product model 10mmx10mm with UPN M00553640. Lot numbers include 32891042 through 34297657 and other specific numbers listed in the recall notice.
Identify the lot number on your device to confirm if it's affected by this recall.
Reach out to Boston Scientific for guidance on whether your device needs replacement.
The outer sheath tip can detach during use, preventing proper stent expansion and prolonging the procedure.
No, but you should check if your device is affected and contact Boston Scientific for next steps.
Contact Boston Scientific to determine if replacement is needed.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1024-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1024-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
