FDA-Device2026-05-20Class IIMISBRANDING
Edwards EVOQUE tricuspid delivery system receives updated labeling for valve functionality warnings
What this means
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
The agency's original wording
Hazard
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Intended for
Adults
Illnesses reported
None reported
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-2172-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.