FDAHealthMarch 27, 2026

Edwards Lifesciences, LLC — Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: March 27, 2026

Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Saudi Arabia, Germany, United Kingdom.

What's affected?

Product: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Brand: Edwards Lifesciences, LLC
Lot code: /UDI:0690103D004EVD000V5

Additional details

All Lots/UDI:0690103D004EVD000V5

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated

View original FDA notice →

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