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Edwards EVOQUE Tricuspid Delivery System
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MEDICAL DEVICE RECALLMODERATE

Edwards EVOQUE Tricuspid Delivery System

Edwards Lifesciences is updating the labeling for the EVOQUE tricuspid delivery system to include a warning about potential functionality issues.

What to do

Review the updated labeling provided by the manufacturer to ensure proper handling and awareness of potential system compromise.

Recalled
Listed
Updated
Recall No.
Z-2172-2026
Agency
FDA
Firm
Edwards Lifesciences, LLC
Recall ID
98633
Status
ONGOING

Why it was recalled

Edwards Lifesciences is issuing a labeling update for the EVOQUE tricuspid valve replacement delivery system to include a warning regarding potential compromise of system functionality. This recall is distributed nationwide.

Is mine affected?

This recall covers the product below. If you have it, yours is affected.

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification