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

The FDA issued a high-risk recall alert for specific lots of Edwards Lifesciences Corp.'s Commander M delivery systems after reports of balloons bursting during procedures, leading to one death and a serious injury. The devices are used to implant replacement mitral heart valves without open-chest surgery, and the company has instructed customers to stop using the affected lots immediately. As a result of the recall, Edwards Lifesciences shares fell by 0.86% to $87.34.