fda_recall · device_recall · high
Edwards Lifesciences, LLC — Class II recall: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Event date
- 2026-05-20 00:00:00Z
- Observed
- 2026-07-09 22:52:31Z
- Source ID
- Z-2172-2026
- Payload hash
- d2d832f5fa1fea86568c81b0…
Summary
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. Status: Ongoing.
Entities
Informational only. Not legal, financial, or medical advice.