Boston Scientific recalls Hot AXIOS Stent delivery systems with risk of peritonitis if rotating luer fitting detaches during use. 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 Hot AXIOS Stent and Electrocautery delivery systems that may detach during use, potentially causing peritonitis. This recall affects specific lot numbers with expiration dates listed in the notice.
The rotating luer fitting at the delivery system handle can become detached during device preparation, stent delivery, or use. If detached, it may cause leakage of internal body fluids into the abdominal cavity, leading to peritonitis.
Patients undergoing stent procedures with the recalled delivery systems are most at risk. Healthcare providers using these devices for medical procedures may also be affected.
Check for lot numbers 26156059, 26167275, 26167276, 26156742, 26156740 on the delivery system packaging. The product expires by October 9 or 12, 2022.
Look for lot numbers 26156059, 26167275, 26167276, 26156742, or 26156740 on the delivery system packaging.
Contact Boston Scientific directly for further instructions if you have the recalled product.
The rotating luer fitting may detach during use, potentially causing leakage of internal body fluids into the abdominal cavity, which can lead to peritonitis.
Check for lot numbers 26156059, 26167275, 26167276, 26156742, or 26156740 on the delivery system packaging. The product expires by October 9 or 12, 2022.
Contact Boston Scientific directly for further instructions if you have the recalled product.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0777-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0777-2021 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.
