Boston Scientific recalls HOT AXIOS Stent and Electrocautery Enhanced Delivery System 6mmx8mm with lot numbers 33336402-34083272. Detached sheath tip can prevent proper stent expansion, 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 6mmx8mm devices with specific lot numbers. The outer sheath tip may detach during use, preventing proper stent expansion and requiring a longer procedure to replace the device.
The outer sheath has a black tip that can detach from the stent device. If it remains around the stent saddle, it prevents the stent from expanding properly, which may require the procedure to be repeated or exchanged.
Medical professionals using the HOT AXIOS Stent system during procedures are most at risk. Patients undergoing stent placement may experience longer procedures due to the detached sheath tip.
Check for the product name 'HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mmx8mm' with lot numbers listed in the recall (33336402 through 34083272).
Look for the lot number on the device packaging or label to confirm if it is in the recalled range (33336402-34083272).
The outer sheath tip can detach during use, preventing proper stent expansion and requiring a longer procedure to replace the device.
Check the lot number on the device packaging or label. If it matches the recalled range (33336402-34083272), contact Boston Scientific for instructions.
The recall states that the detached sheath tip may prevent proper stent expansion, but it does not mention specific injury risks. The hazard is related to procedure prolongation, not direct injury.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1032-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1032-2025 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.
