Boston Scientific recalls HOT AXIOS Stent and Electrocautery Enhanced Delivery System 10mmx10mm units with specific lot numbers due to risk of outer sheath tip detaching, potentially 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 certain HOT AXIOS Stent and Electrocautery-Enhanced Delivery Systems because a part can detach during use, causing the procedure to take longer and requiring a device exchange. This affects medical procedures where the stent is being placed.
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 may require the procedure to be repeated or exchanged, prolonging the time under anesthesia.
Medical professionals using the recalled stent systems during procedures are most at risk. Patients undergoing stent placement with the affected units may experience longer procedures.
Check for the product name 'HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 10mmx10mm' with the UPN code M00553540. The lot numbers listed in the recall include specific sequences like 33169261 through 34731098.
Identify the lot number on your device to confirm if it's in the recalled list (33169261, 33169263, etc.)
Reach out to Boston Scientific for guidance on next steps if your device is affected
The outer sheath's black tip can detach during use, preventing proper stent expansion and requiring procedure exchange.
Check the lot number on your device; affected units have specific lot numbers listed in the recall (e.g., 33169261, 33169263).
Contact Boston Scientific to confirm if your device is affected and get instructions for next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1034-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1034-2025 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.
