Boston Scientific recalls AXIOS Stent and Electrocautery-Enhanced Delivery System 15mmx10mm with specific lot numbers. The outer sheath tip may detach during use, preventing proper stent expansion and requiring device exchange.
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 AXIOS Stent and Electrocautery-Enhanced Delivery Systems because the outer sheath tip can detach during use. This may prevent the stent from expanding properly, leading to longer procedures and requiring a device exchange.
The outer sheath's black tip can detach from the stent during deployment. If it remains around the stent saddle, it blocks proper expansion of the stent, which may require the procedure to be repeated or the device exchanged.
Patients undergoing cardiac procedures who own the recalled stent system with specific lot numbers are most at risk. The hazard affects the device during use, not after it's implanted.
Check the lot numbers listed in the recall: 32891503, 32946481, 32966087, and other specific numbers provided in the recall notice. The product is a 15mmx10mm AXIOS Stent and Electrocautery-Enhanced Delivery System.
Look for the lot number on the device packaging or label to confirm if it's in the recalled list.
If the device is recalled, Boston Scientific will provide instructions for device exchange or repair.
The outer sheath tip can detach during use, preventing proper stent expansion and requiring the procedure to be repeated or the device exchanged.
Check the lot number against the list provided in the recall: 32891503, 32946481, 32966087, and other specific numbers listed in the notice.
No, but if you have the recalled lot number, contact Boston Scientific for instructions on device exchange or repair.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1025-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1025-2025 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.
