Official recall record
Edwards EVOQUE Tricuspid Delivery System
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-04-02
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
Edwards Lifesciences is notifying customers of a voluntary recall (correction) involving a labeling update for the Edwards EVOQUE Tricuspid Valve Replacement System. This recall does not require product return but rather is intended to make a correction to the device labeling to support proper use of the device and help ensure optimal performance.
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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