Official recall record
Advanta V12
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2023-10-11
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Atrium/Getinge is initiating a voluntary medical device recall/removal for the Advanta V12 covered stent system due to an identified manufacturing deficiency that may cause a loss of balloon pressure or inability to hold balloon pressure during Advanta V12 balloon-expandable covered stent deployment. Recall start date: September 25, 2023
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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