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Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System — recall 81391

Health Canada — Medical Devices · Canada · 2025-12-23 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
81391
Date of alert
2025-12-23
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Gastroenterology and urology
Product type
Medical devices
Reported risk: Boston Scientific is initiating a removal of certain AXIOS™ Stent and Electrocautery Enhanced Delivery Systems (6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm). This action is being taken due to increased reports of stent deployment and expansion issues with these configurations. This issue only occurs at the time of delivery of the stent and is expected to be noticed by the physician. Successfully implanted stents are not affected by this issue.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/hot-axiostm-stent-and-electroc

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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