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| HeartWare Ventricular Assist System--Courtesy of HeartWare |
Fresh off a Class I recall, HeartWare International ($HTWR) revealed more safety woes Thursday.
The company issued a voluntary correction notice about earlier-than-expected battery depletion and routine battery handling in the HeartWare Ventricular Assist System due to a spike in customer complaints. The notice contains information for clinicians and patients about monitoring battery performance, recognizing abnormal behaviors and reinforcing proper power management, according to a company statement.
"Similar to the battery in a mobile cell phone, HeartWare batteries will begin to lose charge over time. If a fully-charged battery lasts less than two hours or if the controller switches back-and-forth between batteries, patients are asked to take the affected battery out of service and replace it with a new one," the statement says.
The statement described four deaths reported to HeartWare, which it says were not directly related to a faulty battery. Two occurred after "both sources of power were simultaneously disconnected," a third occurred because of an old battery and the fourth was likely caused by an accidental disconnection of the driveline.
In fact, the now-Class I recall of Ventricular Assist Systems is designed to prevent disconnected drivelines. But the April 30 statement describing the recall says the problem has not resulted in any reported injuries, seemingly at odds with the latest release.
Thursday's statement about battery issues instructs patients to stop using a battery if it acts abnormally and contact their VAD Coordinator for a replacement.
The Ventricular Assist System is designed to provide "a bridge to transplantation." Due to a lack of donated hearts, patients can be on the device for 180 days or more, says FDA.
HeartWare International sold 665 Ventricular Assist Systems in Q1 2014 and had a net loss of $19.4 million on revenues of $66.5 million, according to its earnings release.
- read the release