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

The FDA has issued a high-risk alert regarding a recall of specific lots of Edwards Lifesciences' Commander M delivery systems after reports of balloons bursting during procedures, which resulted in one patient death and a serious injury. The company has advised customers to stop using the affected products and to coordinate returns with company representatives. As a result of the recall, Edwards Lifesciences' stock price fell by 0.86% to $87.34.