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’s Diabetes Unit Gets a Warning Letter from the FDA
Posted January 18, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
FDA Warns on Leadless Heart Pacing Systems
Posted December 8, 2021 in Drug and Medical Device Lawsuits | Product News and Recalls
After observing what it calls “major complications related to cardiac perforation” in patients undergoing pre-market trials for Medtronic’s Micra leadless pacemaker, the FDA has reiterated its warnings to cardiac care providers over the use of leadless devices.
Pacemakers generally come in one of two varieties: either leadless or transvenous. While transvenous pacemakers have been in use for quite some time, the transition to leadless devices has ...
continue reading...Philips CPAP Foam Recall Brings Additional Scrutiny to the Company
Posted December 1, 2021 in Drug and Medical Device Lawsuits | Product News and Recalls
Philips has come under increased scrutiny from federal regulators as investigations into the sound-deadening foam it used on various models of its CPAP machines are revealing much deeper problems within the company.
The foam first came to regulators’ attention this past summer after the discovery that it could degrade and enter the breathing circuits of some of the company’s CPAP machines. Initial reports indicated that the foam particles could cause ...
continue reading...Fallout Begins for Philips CPAP Users in Wake of Recall
Posted September 23, 2021 in Drug and Medical Device Lawsuits | Product News and Recalls
Tens of millions of sleep apnea sufferers across the country are being faced with sleepless nights and frustrating days as they try to chart a course of action since learning that their CPAP machines have been recalled. Millions of Philips DreamStation machines were recently recalled by the manufacturer after it was discovered that the foam used in ...
Starbucks Sued by Texas Woman Over Burn Injuries
Posted September 14, 2021 in Drug and Medical Device Lawsuits | Personal Injury Lawsuits | Product News and Recalls
It’s bad enough to get the wrong order when you swing through a drive-thru but in the case of Texas resident Mary Simms, the incorrect coffee order also left her with first- and second-degree burns.
After being handed the incorrect beverage at a Tomball, Texas Starbucks location, the employee then stopped Simms as she started to drive away and told her that she’d been given the wrong order. ...
continue reading...Boston Scientific Recalls Almost 50,000 Pacemakers
Posted September 10, 2021 in Drug and Medical Device Lawsuits | Product News and Recalls
Nearly seven years’ worth of pacemakers manufactured by Boston Scientific have been recalled over concerns that they can fail to a backup mode and no longer properly pace the patient’s heart. The recall affects 48,000 Ingenio pacemakers manufactured between September 2011 and December 2018. The units continued to be distributed to medical providers through August 1, 2020.
According to the Boston Business Journal, safety mode was created as a ...
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