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 Corp.'s Commander M delivery systems after reports of balloons bursting during procedures, which led to one patient death and a serious injury. The company has advised customers to immediately stop using the affected products and remove them from inventory. As a result of the recall, Edwards Lifesciences' stock price fell by 0.86% to $87.34.