Boston Scientific recalls HOT AXIOS Stent and Electrocautery Enhanced Delivery System 20mmx10mm units with sheath tip detachment risk 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 20mmx10mm devices due to a sheath tip that can detach during use. This may prevent proper stent expansion, requiring a longer procedure to replace the device.
The outer sheath's black tip can detach from the device during use. If it remains around the stent saddle, it prevents the stent from expanding properly, which may require a longer procedure to replace the device.
Medical professionals using the HOT AXIOS Stent system for procedures are likely affected. Those with the specific lot numbers listed in the recall are at risk of procedure delays.
Check the product label for lot numbers: 32865866, 32874910, 32875944, and other numbers listed in the recall. The device is a 20mmx10mm HOT AXIOS Stent with Electrocautery-Enhanced Delivery System.
Look for the lot number on the device label to confirm if it's affected. Affected units have specific lot numbers listed in the recall.
Reach out to Boston Scientific for guidance on next steps if the device is affected.
The outer sheath's black tip can detach during use, preventing proper stent expansion and requiring a longer procedure to replace the device.
Affected lot numbers include 32865866, 32874910, 32875944, and others listed in the recall notice.
No, but if you have the affected lot numbers, contact Boston Scientific for guidance on 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-1036-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1036-2025 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.
