Home › Edwards Lifesciences LLC › EVOQUE
EVOQUE
Edwards Lifesciences LLC · Model 9850EV52US · UDI-DI 00690103217469
NPW
Prescription
0
510(k) clearances
965
Adverse events (80 deaths)
1
Recalls
5
Facilities
Description
EDWARDS EVOQUE VALVE, 52MM
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-27 | Edwards Lifesciences, LLC | Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.