Recall Z-2172-2026— Edwards Lifesciences, LLC

Name: FDA recall Z-2172-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Class II · Ongoing

Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2026-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO. Reason: Labeling update to provide warning if functionality of the valve replacement delivery system is compromised..

Recalling firm: Edwards Lifesciences, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-03-27
Firm location: Irvine, CA, United States

Product description

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Reason for recall

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

Data sourced from openFDA. This site is unofficial and independent of the FDA.