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.

Code information: All Lots/UDI:0690103D004EVD000V5

Distribution pattern: 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.