FDA Issues a Class I Recall of Edwards Lifesciences' Sapien 3 Ultra Delivery System

August 22, 2019—The Food and Drug Administration (FDA) announced a recall of the Edwards Lifesciences' Sapien 3 Ultra delivery system, which is part of the company’s Sapien 3 transcatheter heart valve system. The recall has been issued due to reports of burst balloons during implantation procedures that have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient, which may cause vascular injury, bleeding, or surgical intervention.

The FDA has deemed this a class I recall, which is the most serious type, indicating that these devices may cause serious injuries or death.

Edwards noted that 17 injuries and one death had been reported at the time when the company initiated an Urgent Field Safety Notice to customers in July 2019. In the notice, the FDA noted that no products are being pulled and provided a list of recommendations and instructions for physicians which can be found here.

Affected United States physicians are those who used the Sapien 3 Ultra system starting January 3, 2019 onward.

Those affected may report adverse reactions or quality problems with this device to MedWatch, the FDA Safety Information and Adverse Event Reporting Program, here.