Boston Scientific recalls AXIOS Stent and Delivery System 15mmx10mm UPN M00553750 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 15mmx10mm model because a part can detach during use, causing the procedure to take longer than needed. This could lead to extended time under medical care and potential complications.
The outer sheath's black tip can detach from the stent during use. If it remains around the stent saddle, it prevents proper expansion of the stent, which may require the procedure to be repeated or exchanged.
Patients undergoing stent procedures with the recalled model are affected. Medical professionals using the device during procedures are at risk of extended treatment time.
Check for the model number 15mmx10mm UPN: M00553750 on the device. Affected units have lot numbers 33740402, 33785754, or 34037422 and GTIN 08714729904632.
Identify the model number on the device to confirm if it matches 15mmx10mm UPN: M00553750.
Reach out to Boston Scientific directly for guidance on next steps if the device is recalled.
The outer sheath's black tip can detach during use, preventing proper stent expansion and causing procedure delays.
Check the device model and lot numbers to see if it's affected. Contact Boston Scientific for further instructions.
The recall record does not specify a fix; affected users should contact Boston Scientific directly.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1031-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1031-2025 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.
