The U.S. Food and Drug Administration is alerting health care providers to stop implanting Medtronic’s Heartware Ventricular Assist Device (HVAD) System after reports of patient deaths. Medtronic, one of the world’s largest manufacturers of medical devices, announced its decision to stop the sale and distribution of the HVAD system and warned physicians of “a higher frequency of neurological adverse events and mortality” associated with their device.
Medtronic’s HVAD system was first approved by the FDA in 2012 as a bridge to transplant in patients eligible for heart transplants. The device is surgically implanted inside the chest and connected directly to a failing heart, where it provides mechanical support by pumping blood to the aorta. Recent clinical trials revealed that patients with the HVAD system reported a higher frequency of adverse effects, including stroke, when compared to other left ventricular assist devices (LVAD). Medtronic is informing physicians that HVAD pumps may fail to restart, which can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death.
Dangerous or defective medical devices, such as ventricular assist devices and other implants, can give rise to a product liability claim. Medical devices improve the lives of hundreds of thousands of Texans, but when those devices do more harm than good it may be time to contact a lawyer. You may be entitled to compensation for the bills and lost wages as well as the damages resulting from injuries caused by your medical implant.
If you or someone you love has been injured as the result of a defective product, contact an experienced attorney at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner by calling at 713-742-6008 or 888-229-5094 for your free consultation. The law firm of Abraham, Watkins, Nichols, Agosto, Aziz & Stogner is the longest-standing personal injury firm in Texas, and our attorneys are standing by to assist with your claim.