← FDA ENFORCEMENT
Z-2172-2026Class II

Edwards Lifesciences, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Edwards Lifesciences, LLC
Product type
Device
Status
Ongoing
Report date
2026-05-20
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.
Firm state
CA
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Code / lot info

All Lots/UDI:0690103D004EVD000V5

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →