The U.S. Food and Drug Administration categorized the recall of Edwards Lifesciences Corp.'s Sapien 3 Ultra delivery systems as Class 1, or most severe, due to the risk of serious injuries or even death associated with their use.
The Sapien 3 Ultra delivery system is part of the Sapien 3 transcatheter heart valve system and is used for patients with aortic stenosis.
Aortic stenosis is a heart condition in which the patient's aortic valve narrows and does not open fully, causing a reduction or blockage in blood flow from the heart to the main artery. The procedure for inserting a transcatheter heart valve is less invasive and requires a shorter recovery time compared to open-heart surgery.
The Irvine, Calif.-based medical-device maker said it received reports of burst balloons during implantation procedures, which could lead to vascular injury, bleeding or surgical intervention.
Edwards Lifesciences said it recorded 17 injuries and one death as of July, and added warnings on updated instructions for the use of the device. The affected devices were manufactured between Jan. 23, 2018, and July 16, 2019. The recall applies to 1,585 Sapien 3 Ultra delivery systems.
In August, the FDA expanded the approval of Sapien 3 Ultra to treat patients with aortic stenosis who are at low risk of open-heart surgery.
