The U.S. Food and Drug Administration (FDA) has issued an Early Alert, warning that Edwards Lifesciences is recommending certain delivery systems used for the SAPIEN M3 transcatheter mitral valve (MV) replacement be removed from use.

The recall is due to three reports of balloons bursting during inflation. According to the FDA, "Potential injuries associated with balloon burst include embolism and inability to retrieve the device through the guide sheath."

Read more about lot numbers impacted and additional recommendations for clinicians.

Keywords: United States Food and Drug Administration, ACC Advocacy, Mitral Valve