Heartware International has issued back-to-back warnings about its ventricular assist device (VAD), with the most recent notice involving batteries in the HeartWare Ventricular Assist System.
On April 29, the FDA issued a Class I recall for some HeartWare Ventricular Assist System devices because the locking mechanism in the driveline connector might not properly engage. The failure potentially could stop the pump from pumping and lead to serious adverse events, including death. HeartWare originally reported the problem in December 2013.
HeartWare issued another voluntary correction notice May 1, warning that batteries with the product codes 1650 and 1650-DE might be prone to earlier-than-expected battery depletion. An increase in complaints about the VAD’s battery performance prompted the announcement.
The Framingham, Mass.-based company added that it has not received any reports of deaths related to faulty batteries. Three deaths were reported between Jan. 1, 2011, and March 31, 2014, that potentially involved power source management. In two, both sources of power simultaneously were disconnected and one death was traced to batteries that had exceeded their expected lifetime use.
HeartWare instructed patients and physicians to monitor battery performance for abnormal behavior and review the power source management section in the patient manual. Patients should stop using a suspicious battery and contact their VAD coordinator for a replacement.