FDA recall Z-2172-2026

Product

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Reason for recall

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

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.

Key facts

Status

Ongoing

Initiation date

2026-03-27

Report date

2026-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2172-2026