FDA Orders Recall of Heart Pump
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 manufacturing assembly process. This failure could result in the pump stopping and potentially lead to […]