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 delivery systems that may detach during use, potentially causing peritonitis. This is serious because the detached part could leak internal body fluids into the abdominal cavity.
The rotating luer fitting at 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 who received the recalled Hot AXIOS Stent delivery system for procedures involving stent implantation. Those with recent procedures or ongoing treatment are most at risk.
Check for the product name 'Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS)'. Look for lot number 26130517 with expiration date 10/5/2022.
Identify the lot number and expiration date on the product label to confirm if it matches the recalled units.
Reach out to Boston Scientific directly for guidance on next steps if you have the recalled product.
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 number 26130517 with expiration date 10/5/2022 on the product label.
Contact Boston Scientific directly for guidance on next steps.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0776-2021 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0776-2021 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.
