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 and expiration dates.
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 digestive fluids into the abdominal cavity, leading to peritonitis.
Patients undergoing stent procedures who use the recalled delivery systems are affected. Those with the specific lot numbers and expiration dates listed are most at risk.
Check for lot numbers 26167271, 26152176, or 26167274 on the delivery system packaging. The product expires between October 8, 2021 and October 12, 2021.
Verify the lot number on the delivery system packaging to confirm if it matches the affected numbers: 26167271, 26152176, or 26167274.
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 26167271, 26152176, or 26167274 on the delivery system packaging. The product expires between October 8, 2021 and October 12, 2021.
The recall does not require immediate discontinuation; however, you should check the lot number and expiration date to determine if your device is affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0775-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0775-2021 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.
