Boston Scientific recalls AXIOS Stent and Delivery System 10mmx10mm UPN M00553740 due to reported sheath tip detachment causing procedure delays. Affected units have specific lot numbers and GTIN.
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 its AXIOS Stent and Delivery System 10mmx10mm model (UPN: M00553740) because a sheath tip can detach during use, preventing proper stent expansion and requiring extended procedures. This risk affects medical procedures where the stent must expand correctly.
The outer sheath's black tip can detach from the stent during use. If it remains around the stent saddle, the stent cannot expand properly, leading to extended procedure times to replace the device.
Medical professionals using the AXIOS Stent and Delivery System 10mmx10mm model during procedures are most at risk. Patients undergoing stent procedures with this specific device may experience longer treatment times.
Check for the model number 'AXIOS Stent and Delivery System 10mmx10mm' with UPN M00553740. The lot number is 34477280 and the GTIN is 08714729904625.
Identify the model number on the device as 'AXIOS Stent and Delivery System 10mmx10mm' with UPN M00553740.
The recall is due to reported cases where the outer sheath's black tip can detach during use, preventing proper stent expansion and requiring extended procedures.
Look for the model number 'AXIOS Stent and Delivery System 10mmx10mm' with UPN M00553740, lot number 34477280, and GTIN 08714729904625.
The recall does not specify a remedy, so contact Boston Scientific directly 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-1030-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1030-2025 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.
