Boston Scientific recalls Hot AXIOS Stent and Electrocautery Enhanced Delivery System 20mm x10mm (OUS) due to risk of peritonitis from leakage during procedures. Affected units have specific lot numbers and expiration dates.
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Boston Scientific is recalling a specific stent delivery system that could detach during use, potentially causing peritonitis. This risk occurs if the device leaks internal body fluids into the abdominal cavity during medical procedures.
The rotating luer fitting at the end of the delivery handle can become detached during preparation, stent delivery, or use. If detached, it may cause leakage of digestive fluids into the abdominal cavity, leading to peritonitis.
Patients undergoing procedures with this stent delivery system are most at risk. Healthcare providers using the device for stent implantation may also be affected.
Check for lot numbers: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172. The product expires between October 8 and October 12, 2021.
Look for lot numbers 26167277, 26171099, 26152171, 26171383, 26171380, or 26152172 on the device packaging.
The rotating luer fitting may detach during use, causing leakage of digestive fluids into the abdominal cavity and potentially leading to peritonitis.
Check for lot numbers 26167277, 26171099, 26152171, 26171383, 26171380, or 26152172 with an expiration date between October 8 and October 12, 2021.
The recall does not require immediate stop use; however, if you have the recalled lot numbers, you should check with your healthcare provider about the risks.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0778-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0778-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
