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News Breaks
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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February 27, 2015
07:40 EDTHTWRHeartWare price target raised to $105 from $90 at Leerink
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February 26, 2015
07:03 EDTHTWRHeartWare reports 737 HeartWave Ventricular Assist Systems sold globally
U.S. revenue, generated through the sale of 382 units during the fourth quarter of 2014, was $41.5 million, a 60% increase from $25.9 million in the fourth quarter of 2013.
07:02 EDTHTWRHeartWare reports Q4 non-GAAP EPS (41c), consensus (59c)
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February 23, 2015
07:28 EDTHTWRHeartWare recall should not have material impact long-term, says Canaccord
Canaccord does not believe the voluntary recall issued by HeartWare should not have any material impact on its business long-term, as the serious event rate is relatively low. The recall pertains to a previously known issue and is in effect a continuation of its 2013 corrective action, Canaccord said. The firm reiterated its Buy rating and $115 price target on HeartWare shares.
February 20, 2015
16:35 EDTHTWRHeartWare issues recall of older HeartWare clinical trial controllers
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