Tag: transcatheter_mitral_valve_replacement

FDA Early Alert: Edwards Lifesciences Recalls SAPIEN M3 Delivery Systems After Balloon Bursts, One Death

16 Oct 2026 9:36 a.m. · Source: US Food and Drug Administration

FDA warns of Edwards Lifesciences Commander M delivery system recall over bursting balloons during SAPIEN M3 mitral valve replacement, with one death and one serious injury reported as of October 5.

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