FDA Flags High-Risk Heart Device Recall At Edwards Lifesciences After Patient Death

The U.S. Food and Drug Administration (FDA) issued a high-risk early alert after Edwards Lifesciences Corp. (NYSE:EW) recalled specific lots of its Commander M delivery systems due to reports of balloons bursting during procedures, resulting in one death and a serious injury. Recall Of Commander M Delivery Systems The delivery systems help implant a replacement mitral heart valve through blood vessels, bypassing the need for open-chest surgery. However, the company received three distinct report