Reported May 20, 2026 · Ongoing
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Edwards Lifesciences, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Edwards
- EVOQUE tricuspid delivery system REF9850TDS Sterile EO
- Lot codes and dates
- All Lots/UDI0690103D004EVD000V5
Where it was sold
Why it was recalled
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
This product could cause temporary or reversible health problems — stop using it.
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