The Food and Drug Administration (FDA) on January 11 classified the recall by Edwards LifeSciences (Irvine, California) of its Certitude Delivery System as Class I, the most serious. The system is used for delivery of the Edwards SAPIEN 3 transcatheter aortic heart valve.
The recall was issued because of a molding overflow defect in the button valve within the loader. The overflow material could detach during placement of the delivery system and become an embolus, which could obstruct blood flow to critical organs and/or need to be surgically removed.
The recall includes select lot numbers between 60677270 and 60990824. Manufacturing dates are November 22, 2016, to July 10, 2017. Distribution dates are January 9, 2017, to July 17, 2017.
Posted 01/11/2018] AUDIENCE: Risk Manager, Cardiology, Surgery ISSUE: Edwards LifeSciences is recalling its Certitude Delivery System due to a molding overflow defect in the button valve within the loader. The overflow material could detach during placement of the delivery system and potentially embolize into the patient.