The U.S. Food and Drug Administration issued another Class 1 recall for Medtronic's HeartWare Ventricular Assist Device on Thursday, this time over the risk of battery failure. Medtronic said it is ...
What: After reporting that it is investigating the cause of adverse events in patients participating in a trial of its next-generation heart pump, shares in Heartware International tumbled by over 18% ...
Medtronic's HeartWare HVAD pump system has been hit with a slew of recalls in recent months and the rate of device malfunction reports documented since it's been on the market in an FDA database ...
HeartWare International has agreed to acquire Valtech Cardio, and through that deal, the Framingham-based medical device firm sees a big opportunity to expand its reach in the structural heart market, ...
The struggles at Heartware International continue as the company saw continued year-over-year losses in the second quarter of 2016. Medtronic to buy Heartware for $1.1B Medtronic announced Monday that ...
Five years after Medtronic's billion-dollar purchase of HeartWare International, the company discontinued the device at the center of acquisition — a miniaturized, implantable heart pump — with no ...
Medtronic is recalling one lot of batteries that power its HeartWare Ventricular Assist Device (HVAD) System due to a welding defect that can cause them to malfunction. The US Food and Drug ...
Thousands of HVADs could have faulty battery cells. Nancy Crotti HeartWare International is recalling more than 18,000 batteries for ventricular assist devices it sold between 2013 and 2015, the ...
On 22 March 2006, a 48 year old male patient suffering NYHA Class IV Heart Failure became the first recipient of HeartWare's HVAD mechanical circulatory assist device. The implant was conducted at the ...
FRAMINGHAM, MA — The US Food and Drug Administration issued a formal warning to the makers of a recently approved ventricular assist device (VAD) system (HeartWare, Framingham, MA) for failing to take ...
FRAMINGHAM, Mass., HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, ...
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