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Health Canada Medical devices

Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System

Issued December 23, 2025
Issue
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.
Hazard description
Performance
Product
Product name
Hot AXIOS™ Stent And Electrocautery-Enhanced Delivery System
Reference
ID
RA-81391