Boston Scientific recalls 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 AXIOS Stent delivery systems that may detach during use, potentially causing peritonitis. This recall affects specific lot numbers with expiration dates of October 2022.
The rotating luer fitting at the delivery system handle can become detached during preparation, stent delivery, or use. This detachment may cause delays in procedures or lead to peritonitis if internal body contents leak into the abdominal cavity.
Patients undergoing stent procedures who use the recalled delivery systems are affected. Those with the specific lot numbers and expiration dates are most at risk.
Check for lot numbers 26152465, 26152466, or 26152467 on the delivery system packaging. The expiration date is October 8, 2022.
Look for lot numbers 26152465, 26152466, or 26152467 on the delivery system packaging.
Boston Scientific provides instructions for affected units through their official recall website or customer service.
The rotating luer fitting may detach during use, potentially causing delays in procedures or peritonitis if internal body contents leak into the abdominal cavity.
Check for lot numbers 26152465, 26152466, or 26152467 on the delivery system packaging with an expiration date of October 8, 2022.
The recall does not require immediate discontinuation; affected units should be checked for the specific lot numbers and expiration date.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0774-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0774-2021 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.
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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.
