“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...Medtronic Under Fire for Slow Insulin Pump Fixes
Posted February 28, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
The Food and Drug Administration recently notified executives at medical device manufacturer Medtronic that its efforts at rectifying significant issues within its diabetes business are falling short. “In summary,” the agency said, “your corrective actions are still in process, and you have not yet conducted effectiveness checks to ensure the updated procedures and required employee training will prevent reoccurrence of the identified deficiencies.”
The letter comes ...
continue reading...Medtronic’s Diabetes Unit Gets a Warning Letter from the FDA
Posted January 18, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
Medtronic has recently notified the public that it received a warning letter from the FDA over quality control concerns at its diabetes unit. Included within that letter were issues related to the corporation’s risk assessment, its propensity for device recalls, and the way it handles complaints that are brought to its attention. News of the letter sent Medtronic’s stock price down to some of its lowest ...
