Abbott’s HeartMate Problems Trigger Déjà Vu

If headlines about Abbott’s HeartMate 3 problems are giving you déjà vu, you’re not alone. With three recalls related to the left ventricular assist device (LVAD) so far this year, the news is reminiscent of Medtronic’s defunct HeartWare device.

Most recently, Abbott recalled the HeartMate 3 implant kit after complaint reviews identified blood leakage or air entering the seal interface between the LVAD inflow cannula and the apical cuff. The company noted that in all reports, the issue was observed during implantation of the device. Abbott reports 81 incidents, including 70 injuries and two deaths, related to this issue.

Importantly, the latest HeartMate 3 recall is considered a device correction, not a product removal. Abbott is instructing clinicians to follow standard surgical processes and the existing instructions for use if a blood leak or air entrainment is suspected or observed:

Related:14 Deaths Connected to Latest Abbott HeartMate Recall

Earlier this year, Abbott recalled the HeartMate II and HeartMate 3 systems due to a graft obstruction problem that, as of April 15, had been linked to 273 reported injuries and 14 deaths. That recall also is considered a correction, not a product removal.

Abbott has said it is developing a design solution to minimize the accumulation of debris on the outflow graft. The solution is intended only for HeartMate 3 outflow grafts because the company is discontinuing HeartMate II.

Prior to that news, the Abbott recalled the HeartMate Touch Communication System that monitors HeartMate 3 patients.

The HeartMate devices were developed by Thoratec, which St. Jude Medical bought in 2015 for $3.4 billion. Later, Abbott inherited the technology through its $25 billion acquisition of St. Jude Medical.

How the HeartMate 3 works

The HeartMate 3 is used for both short- and long-term support in pediatric and adult patients with severe left ventricular heart failure. It can be used while waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant isn't an option.

The device is designed to take over the pumping function of the left ventricle, the main pumping chamber of the heart. It diverts blood from the weakened left ventricle and propels it into the body's main artery, the aorta, helping to circulate blood throughout the body.

The video below, courtesy of Abbott, shows how the HeartMate 3 works, how mechanical heart pumps have evolved over time through research and development, and how the device offered "new hope" to one patient.

Medtronic’s discontinuation of the HVAD

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 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.