Boston Scientific recalls AXIOS Stent and Electrocautery Enhanced Delivery System 10mm x10mm (UPN M00553640) due to risk of peritonitis from detached rotating luer fitting during use. Affected units have lot number 26134666 expiring 10/6/2022.
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 their AXIOS Stent and Electrocautery Enhanced Delivery System 10mm x10mm model because a part can detach during use, potentially causing infection in the abdomen. This is serious but only affects medical procedures, not everyday consumers.
The rotating luer fitting at the end of the delivery handle can become detached during preparation, stent delivery, or use. If it detaches, it could cause leakage of stomach, bowel, or bile contents into the abdominal cavity, leading to peritonitis (a serious abdominal infection).
Healthcare professionals using this device for medical procedures are most at risk. Patients receiving the stent treatment may be affected if the device is used improperly.
Check for the product name 'AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm' with lot number 26134666 and expiration date 10/6/2022.
Look for lot number 26134666 on the device packaging or label.
Reach out to Boston Scientific directly for guidance on next steps.
The product is not safe for use as recalled. Boston Scientific has identified a risk of peritonitis if the rotating luer fitting detaches during procedures.
Check for lot number 26134666 and expiration date 10/6/2022 on the device packaging or label.
Contact Boston Scientific directly for guidance on next steps. The recall does not include a specific remedy like returning the device.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0773-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0773-2021 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.
