Edwards Lifesciences Recalls Mitral Delivery Systems After One Death Reported

Edwards Lifesciences has initiated a recall of certain delivery systems used with its Sapien M3 transcatheter mitral valve replacement devices. This action follows three reports of balloons bursting during inflation procedures, with one death and one serious injury associated with the issue. The Food and Drug Administration (FDA) issued an early alert, noting that the problem could lead to an embolism or prevent device retrieval, potentially requiring additional surgical intervention.