Z-2172-2026Class II

Edwards Lifesciences, LLC

Recalling firm

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

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

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

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See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. 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.