FDA Recalls VAD Due to Locking Mechanism Issue

The U.S. Food and Drug Administration (FDA) on April 29 issued a Class I Recall for the HeartWare Ventricular Assist System, also known as the HeartWare Ventricular Assist Device (HVAD), as a result of reports of the driveline connector locking mechanism failing to engage due to faulty manufacturing. "This failure could result in the pump stopping and potentially lead to serious adverse health consequences, including death," noted the FDA.

"Health professionals should promptly arrange a follow up visit with patients having the affected HVAD to inspect the driveline connector," recommended the FDA. "At implant and at each routine clinic visit, inspect the patient's driveline connector for proper locking and to ensure that the connector assembly remains secure."

The recall applies to Catalog Numbers 1100, 1101, 1102, 1103, 1104 and 1205 and Serial Numbers HW001 to HW 11270 and HW20001 to HW 20296. Impacted devices were manufactured between March 6, 2006 and Oct. 17, 2013 and distributed from March 17, 2006 to Nov. 29, 2013. Read the full FDA safety alert.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Mechanical Circulatory Support

Keywords: Heart-Assist Devices, Medical Device Recalls, United States Food and Drug Administration

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