The U.S. Food and Drug Administration (FDA) has warned doctors to stop implanting Medtronic’s HeartWare Ventricular Assist Device (HVAD) in cardiac patients due to safety concerns. The agency recently announced that the medical device, intended to boost blood circulation in patients with heart failure, can stop working unexpectedly and fail to restart. 

Medtronic said it has been unable to pinpoint the root cause in every case but voluntarily pulled its device off the market after reports of more than 100 power failures, 14 deaths, and 13 surgeries to remove the device. There are approximately 2,000 patients in the U.S. and 4,000 worldwide who received the implant. 

HVAD History

As one of the largest global medical device and equipment makers, Medtronic sells thousands of implants to treat heart, neurological, and joint conditions. Its HVAD heart pump received FDA approval in November 2012 for use in patients at risk of end-stage heart failure. The device was said to have a better safety profile than competitors, both as a temporary solution for patients awaiting transplants and as a permanent implant in patients not eligible for surgery. 

In December 2020, Medtronic voluntarily recalled a subset of the HVAD pumps, following reports of power failures and delayed restarts in three production lots. 

Guidance for Patients and Physicians

In a press release issued June 3, 2021, FDA director Bram Zuckerman stated that the agency is “working closely with both Medtronic and Abbott to ensure patient care is optimized during this transition period and that there is an adequate supply of devices available to provide this patient population with options for end-stage heart failure treatment.” The agency has recommended that surgeons treat new implant patients with a safer, alternative heart pump, such as the Abbott Heartmate 3 Left Ventricular Assist System. 

The FDA is advising patients implanted with the device to contact the company for replacement items, such as controllers, batteries, AC/DC adapters, and carrying case. According to the FDA, surgery to remove the device is not automatically recommended. 

Contact an Attorney Experienced in Litigating Defective Medical Device Lawsuits

If you or a loved one has been implanted with the Medtronic HeartWare Ventricular Assist Device, you may be entitled to recover damages for injuries or economic loss caused by the defective product. Please contact the attorneys at Sommers Schwartz today to discuss your situation and your right to compensation.