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Edwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Recalled May 20, 2026 · FDA recall Z-2172-2026 · Edwards Lifesciences
Hazard
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. · FDA Class II
Sold at
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.
Description
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Product
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Manufacturer(s)
Edwards Lifesciences, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →