Edwards EVOQUE tricuspid delivery system REF: recall status

Notice names this product. Edwards Lifesciences’s Edwards EVOQUE tricuspid delivery system REF is named in FDA Class II recall Z-2172-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. Identifying details: All Lots/UDI:0690103D004EVD000V5. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Edwards EVOQUE tricuspid delivery system REF
Company / brand: Edwards Lifesciences
Lot / serial / date codes: All Lots/UDI:0690103D004EVD000V5
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.

Agency product description and boundaries

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Edwards Lifesciences

Recalls naming this model

FDA Class II · Medical device · May 20, 2026

Edwards EVOQUE tricuspid delivery system REF recall — Edwards Lifesciences, LLC

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

Company / brand: Edwards Lifesciences recalls

Affected product: Edwards EVOQUE tricuspid delivery system REF recall status

Official ID Z-2172-2026 · Official record ↗

See all Edwards Lifesciences recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.