Boston Scientific recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mmx8mm (UPN: M00553530) due to risk of sheath tip detaching, preventing stent expansion and prolonging procedures.
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 HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mmx8mm models with specific lot numbers because a sheath tip can detach during use, causing the stent to not expand properly and requiring a procedure exchange. This could lead to longer surgery times and potential complications.
The outer sheath's black tip can detach from the device during use. If it remains around the stent saddle, the stent cannot expand correctly, which may require exchanging the device during surgery. This prolongs the procedure and could lead to complications.
Patients who received the recalled stent or delivery system during procedures between specific dates. Medical professionals using the device for stent placements are most at risk.
Check the product's UPN (M00553530) and lot numbers: 33335139, 33335340, 33336413, 33511491, 34015885, 34065661, 34068983, 34101926. The device is sold under the brand Boston Scientific.
Identify the lot number on the device packaging or label to determine if it is one of the recalled numbers.
Reach out to Boston Scientific directly for assistance with the recall process.
The recalled device is the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mmx8mm with UPN M00553530.
Check the lot numbers: 33335139, 33335340, 33336413, 33511491, 34015885, 34065661, 34068983, or 34101926.
Contact Boston Scientific directly for guidance on the recall process.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1033-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1033-2025 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.
