Edwards Lifesciences recalls Certitude delivery device for Sapien 3 valve

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 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. The risk is that the overflow material could detach and embolize into the patient. Edwards warned customers of the issue last July, asking them to check their inventory for Certitude systems affected by the recall and return any found to the Irvine, Calif.-based company, the FDA said. The post Edwards Lifesciences recalls Certitude delivery device for Sapien 3 valve appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Catheters Recalls Replacement Heart Valves Edwards Lifesciences Source Type: news