The Sapien 3 is a transcatheter aortic valve replacement designed to treat aortic stenosis.
Edwards Lifesciences (NYSE:EW) is recalling the Certitude delivery device used with its Sapien 3 replacement heart valve on the risk that a molding defect could embolize, the FDA said today.
The Sapien 3 is a transcatheter aortic valve replacement designed to treat aortic stenosis. During implantation the valve is crimped to Certitude’s balloon before either transapical or transaortic insertion into the body.
The recall, of some 1,730 devices from lots made between Nov. 22, 2016, and July 10 of last year, is due to a molding overflow defect in the button valve within Certitude’s loader, according to the federal safety watchdog.
