Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
Category: patient safety
FDA Announces Recall of Heart Pumps Linked to Deaths and Injuries
Some pumps used in end-stage heart failure caused a buildup of biological material that blocks blood flow from the device to the heart’s aorta. The FDA’s recall affects nearly 14,000 devices.
‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea
The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.
‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea
The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.
Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records
Thousands of medical devices are sold, and even implanted, with no safety tests.
Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk?
The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death.
Shaved Costs, High Risk, Maximum Profits: Regulators Worry About Florida’s Butt Lift Boom
Social media marketing lures people to South Florida’s lucrative cosmetic surgery scene with the promise of cheap Brazilian butt lifts. But some researchers, patient advocates, and surgeon groups say that the risks of the procedure are generally not understood by prospective patients, and that an unsafe number of surgeries can be performed per day in office settings, maximizing profits.
Sick Profit: Investigating Private Equity’s Stealthy Takeover of Health Care Across Cities and Specialties
Private equity firms have shelled out almost $1 trillion to acquire nearly 8,000 health care businesses, in deals almost always hidden from federal regulators. The result: higher prices, lawsuits, and complaints about care.
At US Hospitals, a Drug Mix-Up Is Just a Few Keystrokes Away
After a Tennessee nurse killed a patient because of a drug error, the companies behind hospital medication cabinets said they’d make the devices safer. But did they?
Health Care Paradox: Medicare Penalizes Dozens of Hospitals It Also Gives Five Stars
Among the 764 hospitals hit with a 1% reduction in Medicare payments this year for having high numbers of patient infections and avoidable complications are more than three dozen that Medicare also ranks as among the best in the country.
