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Edwards Lifesciences, LLC recalls
17 federal recalls on file, showing the 1 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Edwards Lifesciences, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-05-20FDA-DeviceClass IIEdwards EVOQUE tricuspid delivery system labeling updated
Edwards Lifesciences has updated the labeling for its EVOQUE tricuspid delivery system to include a warning about potential loss of device functionality during valve replacement procedures. This is a labeling change to help clinicians recognize and respond to compromised system performance. No injuries have been reported.
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