Medical devices
FDA warns about Edwards SAPIEN M3 delivery systems after balloon bursts
Edwards recommends removing certain SAPIEN M3 delivery systems from use after three reports of balloons bursting during inflation.
The FDA has issued an Early Alert about a delivery system issue involving Edwards Lifesciences’ SAPIEN M3 transcatheter mitral valve replacement. The agency said Edwards is recommending that certain delivery systems used with the valve be removed from use.
The recall is due to three reports of balloons bursting during inflation. The FDA said potential injuries associated with a balloon burst include embolism and inability to retrieve the device through the guide sheath. The report describes the affected equipment as certain delivery systems used with the SAPIEN M3 for transcatheter mitral valve replacement. Edwards is recommending those systems be removed from use, according to the FDA alert.
