Medtronic Pulled the Plug on This Device in 2021

As Abbott faces its third HeartMate 3 recall this year, the news brings to mind Medtronic's defunct HeartWare device.

After Medtronic pulled the plug on its HeartWare left ventricle assist device (HVAD) in 2021, Abbott stepped up to support the growing demand for circulatory support devices with HeartMate 3.

For Medtronic, the final straw was a growing body of evidence indicating a higher frequency of neurological adverse events, such as stroke, with the HVAD compared to other circulatory support devices available at that time. But the HeartWare device had been a problem for years before the company stopped selling the HVAD.

Medtronic did, however, develop a support program for patients who have had an HVAD implanted and for caregivers and health care professionals who participate in their care. An independent panel of clinician advisors helped develop the program to ensure the ongoing care and safety of patients currently supported by the HVAD system.

A history of HVAD recalls

Medtronic bought HeartWare for $1.1 billion in 2016. By that time, the device had already been impacted by one major recall. In 2015, HeartWare recalled more than 18,000 devices due to faulty batteries.

It wasn’t long after Medtronic bought HeartWare that the HVAD system was involved in two other recalls. The company had to recall 8,799 HVAD controllers that were potentially damaged from exposure to moisture through loose power and data connectors. Medtronic also recalled 350 implant kits from hospital inventory that were susceptible to electrical faults and connection failures from fluid entering the driveline-to-controller connector.

A couple years later, Medtronic recalled 204,017 HVADs due to an interruption of the electrical connection between the device’s power source and controller.

In May of 2020, the company recalled the HVAD’s outflow graft and outflow graft strain relief, citing a risk of breaks and tears during the pre-implant pump assembly process.

The final recall related to the HVAD came in November 2020. That recall was for the pump implant kit because there were concerns about the device failing to initially start, restart, or experiencing a delay in restarting after the pump stops.