The U.S. Food and Drug Administration has issued a recall for the HeartWare Ventricular Assist System, which is used as a bridge to cardiac transplantation in patients who are at risk of death from advanced heart failure. The company received reports where the driveline connector locking mechanism has failed to engage as a result of a faulty manufacturing assembly process. This failure could result in the pump stopping and potentially lead to serious adverse health consequences, including death. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm395252.htm |