Boston Scientific recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 15mmx15mm (UPN M00553570) due to risk of outer sheath tip detaching, causing procedure delays. Affected units have 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 HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 15mmx15mm (UPN M00553570) because the outer sheath tip can detach during use, potentially causing the procedure to last longer than needed. This is a risk for medical professionals performing the procedure.
The outer sheath's black tip can detach from the device during use. If it remains around the stent saddle, it prevents proper expansion of the stent, which could prolong the procedure and require exchanging the device for a new one.
Medical professionals using the HOT AXIOS Stent system during procedures are most at risk. Patients receiving the procedure may be affected if the device is used without the recall fix.
Check for the product name 'HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 15mmx15mm' with UPN M00553570. Affected units have specific lot numbers: 32878539, 33336847, 33338446, 33775901, 33795273, 33900261, 33900262, 34076575, 34083270, 34172108, 34172109.
Identify the product name and UPN M00553570 to confirm if your device is affected.
The outer sheath tip can detach during use, preventing proper stent expansion and prolonging the procedure.
The recall record does not specify a remedy, so contact Boston Scientific for guidance.
Check for the product name 'HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 15mmx15mm' with UPN M00553570 and the listed lot numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1037-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1037-2025 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.
