FDAFDA · Food and drugs·Recall number Z-2172-2026
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Published May 20, 2026 · Recall initiated: March 27, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Edwards Lifesciences, LLC
- Distributor
- 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.
- Lot
- All Lots/UDI:0690103D004EVD000V5
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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