The U.S. Food and Drug Administration (FDA) has issued a class I recall for the SAPIEN 3 Ultra Delivery System, manufactured by Edwards Lifesciences, due to reports of burst balloons during implantation procedures. According to the Agency, potential implications for using an affected product may include "vascular injury, bleeding, or surgical intervention" due to difficulties retrieving the valve into the catheter and withdrawing the system from the patient. The recall impacts those who have used Edwards SAPIEN 3 Ultra Transcatheter Heart System starting January 3, 2019. Edwards Lifesciences sent an Urgent Field Safety Notice to customers on July 9 with recommendations and instructions for physicians. These instructions can be found with the FDA’s full safety alert.

Keywords: ACC Advocacy, Vascular System Injuries, United States Food and Drug Administration, Hemorrhage, Catheters

< Back to Listings