Edwards Lifesciences, LLC: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Hazard

Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.

Details from the source

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. Lot/code info: All Lots/UDI:0690103D004EVD000V5

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.