Even a year after being laid to rest, the troubled HeartWare Ventricular Assist Device, or HVAD, system is still causing problems for Medtronic.
The devicemaker—which acquired the entire HeartWare company for $1.1 billion in 2016—opted to discontinue the HVAD system last June. The decision was the culmination of a decade’s worth of safety issues and complaints linked to the device, which was designed to help the heart pump blood to the rest of the body in patients with heart failure.
When it took the heart pump off the market, Medtronic recommended that the approximately 4,000 people already implanted with the device not seek removal, since that procedure could be more dangerous than any potential defects identified with the system itself.
Still, the issues for that group of HeartWare customers continue. Earlier this year, Medtronic identified yet another safety risk with the device. And while it was initially announced to patients and healthcare providers in an urgent medical device correction at the end of April, the safety issue has since been upgraded to a full-blown recall, which landed the FDA’s most serious Class I rating this week.
The recall spans more than 1,600 HVAD pump implant kits distributed in the U.S. between October 2006 and last June, when the device was removed from the market.
Medtronic discovered the issue after a handful of patients began to experience what appeared to be symptoms of pump thrombosis, where an implant forms a blockage in the flow of blood either to or from the heart.
After those patients’ devices had been removed, they were sent to Medtronic for examination. The company discovered a welding defect that had allowed moisture to seep into the center of the pumps, causing their internal magnets to corrode and become demagnetized. That, in turn, caused the pumps to begin rotating incorrectly.
If that happens and a heart pump malfunctions, it could lead to severe injuries such as organ dysfunction or stroke, or even death. It may also require the pump to be removed in a major surgery that carries its own share of risks.
So far, according to the FDA, Medtronic has received reports of one death and two injuries regarding the device issue. The agency’s tally differs from Medtronic’s initial report in April, which stated that of the three patients who had their pumps replaced after discovering the issue, two died within a month of the exchange.
As Medtronic continues to investigate the issue, it has asked healthcare providers to return all unused HVAD pump implant kits. It also urged physicians to immediately report to the company any cases in which implanted patients begin to exhibit possible signs of the defect, which include abnormal grinding sounds or vibrations from the pump, power spikes in their log files, slowed motor speed, elevations in the enzyme lactate dehydrogenase, and dizziness or lightheadedness.