Edwards Lifesciences, LLC recalls Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Recalling company
- Edwards Lifesciences, LLC
- Product
- Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Reason
- Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 27, 2026
- Reported
- May 20, 2026
- 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.
- Status
- Ongoing
- Lot / codes
- All Lots/UDI:0690103D004EVD000V5
- Company location
- Irvine, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2172-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2172-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.