FDA: Class I recall of Edwards Lifesciences SAPIEN 3 Ultra Delivery System

Editor's Note

The Food and Drug Administration on August 22 identified the recall by Edwards Lifesciences of all lots of its SAPIEN 3 Ultra Delivery System as Class I, the most serious. The delivery system is part of the Edwards SAPIEN 3 Transcatheter Heart Valve System.

The recall was initiated because Edwards Lifesciences has received reports of burst balloons during implantation procedures, which have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient. Seventeen injuries and one death have been reported.