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.
Review the updated labeling provided by the manufacturer to ensure proper handling and awareness of potential system compromise.
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?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Recall #
- Z-2172-2026
Where it was sold
Distributed nationwide.
Official source
Editorial summary by Recall Canary · last updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification