Official recall record
Hot AXIOS™ Stent and Electrocautery Enhanced Delivery System
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-01-08
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Boston Scientific is initiating a removal of specific lots of the AXIOS™ Stent and Electrocautery Enhanced Delivery System due to reports of the outer sheath distal black tip detaching from the device. Boston Scientific has received seven (7) reports of this issue between June 1, 2023, and present day. Recall start date: December 20, 2024
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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