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

Medical deviceClass IIOngoing

Summary: Edwards Lifesciences, LLC is recalling 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.

What is being recalled

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

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. (states named: Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia)

How to tell if yours is affected

All Lots/UDI:0690103D004EVD000V5

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Edwards Lifesciences, LLC · all medical device recalls · recalls from March 2026

Official FDA record