Medical Device Recall: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Edwards Lifesciences, LLC · March 27, 2026
Reason for Recall
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Distribution
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.
States Affected
NATIONWIDE
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2172-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.