Boston Scientific recalls AXIOS Stent 15mmx15mm models with specific lot numbers due to risk of sheath tip detaching, potentially prolonging procedures. Affected units may need replacement.
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 a part can detach during use, causing the procedure to take longer and requiring device exchange. This risk affects medical procedures where timely stent deployment is critical.
The outer sheath's black tip can detach from the device during use. If it remains around the stent saddle, it prevents proper stent expansion, leading to extended procedure times and the need for device replacement.
Healthcare professionals using the AXIOS Stent system during procedures are most at risk. Patients undergoing stent placements with the recalled models may experience longer procedures.
Check for the model 'AXIOS Stent 15mmx15mm' with lot numbers listed in the recall notice. The specific lot numbers include 32901294, 33223930, and others as detailed in the official recall list.
Identify the lot number on the device packaging or label to confirm if it matches the recalled list.
Reach out to Boston Scientific directly for guidance on next steps if the device is recalled.
The outer sheath's black tip can detach during use, preventing proper stent expansion and requiring device exchange.
Check the lot number on your device packaging; affected units have specific lot numbers listed in the recall notice.
No, but if you have the recalled lot numbers, contact Boston Scientific for instructions 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-1027-2025 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1027-2025 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.
