Official recall notice

FDA DeviceClass IINotable

Edwards EVOQUE tricuspid delivery system Recall (May 2026)

Product: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Recall date
2026-05-20
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Verify with the official notice →
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