“It sounded like a cement mixer.” This is how one Medtronic HeartWare HVAD patient described the sound coming from deep within his chest after the device became clogged with a blood clot. Years after the initial recall was ordered under a Class I status by the FDA, thousands of patients across the country are faced with a life-threatening dilemma: do they keep the device and hope it doesn’t fail them or do they ...
As Heartware Recalls Continue, Patients Cope with the Time Bomb in Their Chests
Posted December 3, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
The HeartWare HVAD System is Under a Class I Recall…Again
Posted July 27, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
The 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 ...
Medtronic Braces as Additional Problems Found with HeartWare Device
Posted June 8, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
Anyone 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 ...
FDA Faces Congressional Investigation Over Lack of Reaction to Heart Device Recall
Posted April 14, 2022 in Product News and Recalls
The 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 ...
continue reading...Another Day, Another Story of the FDA Failing the American People
Posted August 31, 2021 in Drug and Medical Device Lawsuits | Product News and Recalls
In 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 ...
continue reading...Medtronic Heart Pump Recalled Over Potentially Fatal Flaw
Posted October 12, 2016 in Drug and Medical Device Lawsuits | Product News and Recalls
Last 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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