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 ...
Philips Threatened with Massive Refunds as FDA Grows Impatient Over Respiratory Devices
Posted May 31, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
The FDA is not happy with the pace of Philips’ response to an issue with multiple lines of respiratory devices. The corporation recalled millions of the devices almost a year ago and has yet to provide customers at home and at hospitals with a plan to replace the machines that, according to the recall, could be sending carcinogenic foam particles into their lungs and increasing their ...
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 ...
The U.S. Food and Drug Administration (FDA) has announced a Class I recall of all lots of Macquet Medical Systems’ TigerPaw System II. The TigerPaw System II is an implantable device used to close ruptured tissue in the left atrial appendage of the heart. However, according to the FDA, if not completely closed, the TigerPaw System II may result in tissue tears or bleeding during use ...
