Edwards Lifesciences, LLC
Edwards Lifesciences, LLC: 2 recalls posted by FDA since May 2026; 1 rated high risk.
All recalls (2)
Edwards Lifesciences Commander M Delivery System
The Edwards Commander M Delivery System may have a manufacturing issue causing cardiovascular balloon rupturing.
Edwards EVOQUE Tricuspid Delivery System
The Edwards Evoque tricupid delivery system may have compromised functionality, which could affect the valve replacement.
