News about medical devices

The FDA last week issued a safety notice for certain delivery systems used in Edwards Lifesciences' Sapien M3 transcatheter mitral valve replacement, after three balloon bursts occurred during inflation. As of Oct. 5, Edwards reported three incidents, including one death and one serious injury. The company told customers to stop using and return devices from four lot numbers of its Commander M delivery systems. Since the Oct. 15 alert, Edwards shares (EW) have fallen 1.3% to $86.94, with a market cap of about $50 billion.