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May 1, 2014
06:58 EDTHTWRHeartWare issues voluntary device correction for HeartWare batteries
HeartWare issued a voluntary Urgent Medical Device Correction related to all HeartWare Ventricular Assist System batteries, product codes 1650 and 1650-DE. In letters to clinicians and patients, the company reports an observed increase in complaints related to earlier-than-expected battery depletion and routine battery handling. HeartWare is providing information to assist patients and clinicians in monitoring battery performance, recognizing abnormal behaviors and reinforcing proper power management. Premature or unrecognized deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. If a battery shows abnormal behavior, patients are instructed to stop using that battery and contact their VAD Coordinator for a replacement. No deaths have been reported to HeartWare that were directly related to a faulty battery. However, between January 1, 2011 and March 31, three deaths were reported that were potentially related to power source management. Of those, two patient deaths occurred after both sources of power were simultaneously disconnected; the third patient had batteries that far exceeded their expected useful life. A fourth death was originally reported as possibly related to power management, but was later determined to be more likely related to an accidental disconnection of the driveline. Clinicians and patients are encouraged to review the correction letters and the Patient Manual to ensure proper power management.
News For HTWR From The Last 14 Days
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September 17, 2014
11:41 EDTHTWRLeerink medical devices analyst holds an analyst/industry conference call
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September 15, 2014
07:21 EDTHTWRHeart Failure Society of America to hold annual meeting
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