Boston Scientific recalls AXIOS Stent and Electrocautery-Enhanced Delivery System 20mmx10mm 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 a specific size of AXIOS Stent and delivery system because a part can detach during use, causing the procedure to take longer and requiring a device exchange. This could lead to extended surgery time and increased risk for patients.
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 extended and the device replaced.
Patients undergoing cardiac procedures who use this specific stent model and delivery system are most at risk. The recall affects devices with the listed lot numbers sold between 2020 and 2023.
Check the lot number on the device packaging or label. The recalled model is the AXIOS Stent and Electrocautery-Enhanced Delivery System 20mmx10mm with specific lot numbers listed in the recall notice.
Look for the lot number on the device packaging or label to confirm if it's in the recalled list.
The outer sheath's black tip can detach during use, preventing proper stent expansion and potentially requiring the procedure to be extended and the device replaced.
Check the lot number on the device packaging or label. The recalled model is the AXIOS Stent and Electrocautery-Enhanced Delivery System 20mmx10mm with specific lot numbers listed in the recall notice.
Check the lot number to confirm if it's affected. If it is, 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-1026-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1026-2025 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.
