Posts Tagged 'heartware'

The HeartWare HVAD System is Under a Class I Recall…Again

Medtronic heartware system again under Class I recallThe FDA recently announced that the HeartWare HVAD system was being recalled by medical device manufacturer MedTronic over concerns of battery failure. The recall marks the second time the device has been recalled, with both occurrences falling under Class I status. The Class I recall is the FDA’s most severe recall classification and is reserved for instances where the continued use of the recalled item ...

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Medtronic Braces as Additional Problems Found with HeartWare Device

Medtronic sees reports of pump thrombosis with HVAD Heartware pumpAnyone familiar with the process of buying a pre-owned vehicle knows how important the test drive is. Not only is this the time when you get a feel for it and see how it handles, but it is also the purchaser’s chance to determine if the vehicle is running properly. Your ears listen to the engine for odd sounds, and you give the brakes a good ...

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FDA Faces Congressional Investigation Over Lack of Reaction to Heart Device Recall

congress investigating failures at FDAThe FDA’s ongoing failures to protect and represent the American people have finally caught the eyes of congressional legislators and the agency now finds itself on the hot seat over the way it handled – or failed to handle – the Medtronic HeartWare Ventricular Assist Device recall.

14 patients died and 13 cardiac pumps had to be removed from patients’ chests before the agency tasked with protecting the ...

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Another Day, Another Story of the FDA Failing the American People

fda knowingly allowed faulty device to be implanted in patientsIn a narrative that has become all too familiar when referring to one of the most openly corrupt institutions in the American government, reports have surfaced that the FDA knowingly allowed a faulty medical device to make its way into unwitting patients. This time the device in question is quite literally responsible for keeping patients’ blood circulating through their bodies.

The HeartWare Ventricular Assist Device, or HVAD ...

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Medtronic Heart Pump Recalled Over Potentially Fatal Flaw

medtronic heartware hvad system under recallLast year, medical devices manufacturer Medtronic bought HeartWare, the company behind a heart pump known as the HVAD system. The deal cost Medtronic $1 billion.

Prior to the purchase, HeartWare had received not one, but two safety letters from the U.S. Food and Drug Administration over issues related to the HVAD pump. These letters detailed agency concerns over the effects of moisture on the HVAD system. Medtronic ...

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FDA Warns of Adverse Events with Heart Devices

fda issues warning on heart devicesThe U.S. Food and Drug Administration (FDA) has issued a safety communication warning of serious adverse events associated with two implantable left ventricular assist devices. The two heart systems, which happen to be the only implantable devices of their kind approved by the FDA, are the HeartMate II Left Ventricular Assist System, manufactured by Thoratec Corporation, and the HeartWare Ventricular Assist System, manufactured by HeartWare, Inc.

According ...

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