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Health Canada Medical devices

Edwards EVOQUE Tricuspid Delivery System

Issued April 2, 2026
Issue
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.
Hazard description
Labelling and packaging
Product
Product name
Edwards EVOQUE Tricuspid Delivery System
Reference
ID
RA-81834