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 ...
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
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 ...
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 ...
Medtronic Heart Catheter Recalled After Injuries, Deaths
Posted November 16, 2020 in Drug and Medical Device Lawsuits | Product News and Recalls
A recall has been issued for the Medtronic Rashkind balloon septostomy catheter. 142 of the devices are covered under the federal recall action and were distributed throughout the United States between May 2018 and August 2020.
According to the FDA, the recall was issued because “quality issues…may lead to the device breaking, separating or failing during use.” The agency goes on to say that “if this occurs, ...
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