Skip to main content

Ongoing FDAEvent 98633 (5 months ago)

Edwards EVOQUE Tricuspid Delivery System

The Edwards EVOQUE tricuspid delivery system has a labeling update to warn if its function is compromised.

Moderate risk

Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

What to do

What happened

Edwards Lifesciences, LLC, of Irvine, California, began a recall of the Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO on March 27, 2026, to update labeling with a warning if the functionality of the valve replacement delivery system is compromised. The FDA added the recall to its Enforcement Report and classified it on May 13, 2026, with distribution worldwide, including nationwide in the U.S. and in Saudi Arabia, Germany, and the United Kingdom.

Summary by Recall Canary from the FDA notice.

More labeling error recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

  1. Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

    Lot
    All Lots/UDI:0690103D004EVD000V5

Details

Company began the recall
Sold in

Worldwide - US Nationwide distribution including in the states of 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 and the countries of Saudi Arabia, Germany, United Kingdom.

Event ID
98633
Recall No.
Z-2172-2026
Company
Edwards Lifesciences, LLCIrvine, California
Hazard
Labeling error

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

More medical device recalls

See all

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration