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

Recall date

March 27, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2172-2026

FDA classification

Class II

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO