United StatesEdwards EVOQUE tricuspid delivery system (REF: 9850TDS; All Lots/UDI: 0690103D004EVD000V5) is being recalled; units were distributed sterile EO worldwide, including US nationwide and several other countries. The recall is for a labeling update to provide a warning if the functionality of the valve replacement delivery system is compromised.
What's being recalled
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Recalling firm: Edwards Lifesciences, LLC, Irvine, CA, United States.
How to identify it
All Lots/UDI:0690103D004EVD000V5
The hazard
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)