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

Edwards Lifesciences Corp. (NYSE: EW) has issued a recall for specific lots of its Commander M delivery systems following reports of balloons bursting during procedures, which have resulted in one patient death and a serious injury. The FDA has flagged this as a high-risk alert, advising customers to stop using the affected products immediately. As a result of the recall, Edwards Lifesciences shares fell 0.86% to $87.34.