FDA-Device2026-05-20Class IIMISBRANDING
Edwards EVOQUE tricuspid delivery system receives updated labeling for valve functionality warnings
FALSE CLAIMSNationwide distribution
Edwards EVOQUE tricuspid delivery system labeling updated
Edwards Lifesciences has updated the labeling for its EVOQUE tricuspid delivery system to include a warning about potential loss of device functionality during valve replacement procedures. This is a labeling change to help clinicians recognize and respond to compromised system performance. No injuries have been reported.
- Review the updated labeling for the EVOQUE tricuspid delivery system (REF:9850TDS) if you use or manage this device in a clinical setting
- Contact Edwards Lifesciences directly with questions about the labeling update or device functionality
Hazard
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Sold states
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.
Manufactured in
1 Edwards Way, Irvine, CA, United States
Products
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2172-2026Don't want to check this manually?
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