← Back to all recalls
MEDICAL DEVICE RECALLMODERATE
Edwards EVOQUE Tricuspid Delivery System
Edwards Lifesciences is updating labeling for the EVOQUE tricuspid delivery system to include a warning about potential functionality loss.
What to do
Review the updated labeling instructions provided by the manufacturer and contact your clinical representative if you have questions regarding the use of this device.
Why it was recalled
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
How to identify it
Edwards EVOQUE tricuspid delivery system
Where it was sold
Distributed in US.
Official source
← Back to all recalls
Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification