September 24, 2021 · FLEMING | NOLEN | JEZ, L.L.P.
Medtronic discontinues its Heart Ware Heart Ventricular Assist Device Pump
Medtronic discontinued its Heart Ware Heart Ventricular Assist Device pump this June 2021 amid a series of Class I recalls and numerous reports of patient injuries and deaths associated with the product. Since 2013, there was approximately 27 Class I recalls and 9 Class II recalls between pre-market approval November 2012 to April 2021.
The Heart Ware device is an implantable heart pump that treats advanced cases of heart failure. The system is used as a bridge to cardiac transplants in patients who are at risk o death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients where new transplants are not planned. The device uses a propeller-like system to push a person’s blood when the heart’s main pumping chamber is too weak to do the work on its own. Past studies have shown that such pumps get gummed up with blood clots as often as 4 percent of the time.
After more than 19, 000 devices have been implanted, Medtronic and the FDA announced a halt to HVAD sales and implants. Three thousand reports detail patient deaths that may have been caused or aggravated by the device.
Medtronic HVAD System Complications
- Neurological dysfunction;
- Heart attack;
- Internal Bleeding/ hemorrhage;
- Right ventricle failure;
Physicians and hospitals will have to manage patients transitioning to a new product and it won’t be simple given the product’s vital medical usage, complications can have serious implications for patients. Defective medical devices can give rise to a product liability claim when they do more harm than good, if you find yourself in this situation it may be time to contact an attorney.