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 ...
February 25, 2011 (Milwaukee, Wisconsin)— A patient implanted with the HeartWare ventricular assist device (VAD) (HeartWare, Framingham, MA) suffered an intracranial hemorrhage after being treated for ...
The US Food and Drug Administration (FDA) is notifying physicians of a Class I recall of unimplanted HeartWare ventricular assist device (VAD) implant kits, initiated voluntarily by the company in ...
The US Food and Drug Administration (FDA) is notifying physicians and hospitals of a class I recall of batteries in the HeartWare ventricular assist device (VAD), which is used in patients with ...
HeartWare International Inc. (HTWR) recently received approval from Health Canada to market its HeartWare Ventricular Assist Device (HVAD) as a bridge to heart transplantation in patients with ...
The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant. Approval of the device had been expected after ...
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 ...
The FDA today approved the HeartWare Ventricular Assist System — a left ventricular assist device — to support heart function and blood flow in patients with end-stage HF who are awaiting a heart ...
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