Edwards Lifesciences, Llc: Percutaneously Delivered Prostheses And Tricuspid Valves
- Recalling firm
- Edwards Lifesciences, LLC
- Product
- Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Reason
- Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-27
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/41e03fe5-1047-4977-a442-4f8265fa1aa8