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Medium severity

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateMarch 27, 2026
ReportedMay 20, 2026
Recalling firmEdwards Lifesciences, LLC
Country / regionUnited States CA

Hazard

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

Affected products

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