The U.S. Food and Drug Administration (FDA) issued a Class I recall Thursday for the Edwards SAPIEN 3 Ultra Delivery System.
The delivery system is part of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Edwards Lifesciences, Irvine, California). The delivery system deploys the balloon-expandable Edward SAPIEN 3 Ultra transcatheter heart valve as part of a transcatheter aortic valve replacement (TAVR) procedure.
Edwards Lifesciences has received reports of burst balloons during implantation procedures, which have resulted in significant difficulty retrieving the valve and withdrawing it from the patient, according to the FDA recall notice.
The FDA said that 17 injuries and one death were reported when Edwards initiated a field corrective action in July.
A Class I recall is the FDA’s most serious type of recall, indicating that use of the affected devices may cause serious injuries or death, the agency said.
Edwards sent an urgent field safety notice to customers on July 9 with recommendations and instructions for physicians. Those recommendations are detailed again in the FDA’s notice. That notice prompted Health Canada, the Canadian government’s health regulatory agency, to issue a recall on July 16.
The FDA approved the SAPIEN 3 Ultra in December for TAVR to treat severe symptomatic aortic stenosis in patients at intermediate or greater risk of surgical mortality. That approval was extended Friday to patients at low surgical risk for the Ultra as well as the Edwards SAPIEN 3 and self-expanding Metronic Evolut transcatheter heart valves.
The FDA asks that health care professionals and consumers report adverse reactions or quality problems to the agency’s MedWatch program.