ISSUE<\/strong>: HeartWare, Inc. received reports where the driveline connector locking mechanism 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.<\/p>\n BACKGROUND<\/strong>: The HeartWare Ventricular Assist System is used as a bridge to cardiac transplantation in patients who are at risk of death from advanced heart failure.\u00a0 Also known as HeartWare Ventricular Assist Device (HVAD), the system is\u00a0designed for in-hospital and out-of-hospital settings, including transportation by fix-wing aircraft or helicopter.<\/p>\n Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Affected products were manufactured from March 6, 2006 through October 17, 2013 and distributed from March 17, 2006 through November 29, 2013.<\/p>\n RECOMMENDATION<\/strong>: Health professionals should promptly (more…)<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":" HeartWare, Inc., Heartware Ventricular Assist System: Class I Recall – Locking Mechanism of Pump Driveline Connector May Fail to Engage ISSUE: HeartWare, Inc. received reports where the driveline connector locking mechanism failed to engage as a result of a faulty…<\/span><\/p>\n
\nSerial Numbers: HW001 to HW 11270 and HW20001 to HW 20296.<\/p>\n