Study Links HeartMate 3 LVAD to Neurological Risks

HeartMate 3 implants have been known to present problems for years, resulting in multiple recalls, patient deaths and lawsuits.

New research suggests that patients implanted with the HeartMate 3 left ventricular assist device (LVAD) face substantial risks of strokes and other neurological complications, which are associated with significantly reduced survival.

A group of U.S. researchers published a study in the Journal of the American College of Cardiology (JACC) journal, Heart Failure, on October 6, warning that they found LVAD recipients developed nonstroke neurological adverse events (NAEs), leading to deaths among implant recipients.

HeartMate 3 LVAD Recalls

The HeartMate 3 LVAD was first introduced in 2011 as a medical implant used to help patients with advanced left ventricular heart failure circulate blood throughout the body. The implant is a heart pump controlled by an external controller and a HeartMate Mobile Power Unit, which is employed when the patient is away from a stationary power source.

However, the last several years have seen the HeartMate system beset with problems, injuries and fatalities, resulting in several HeartMate 3 recalls and safety warnings. HeartMate 3 recalls were announced in May 2024 and April 2025.

The 2024 recall came after reports of blood leaks and air embolisms, often requiring emergency surgery to address. The recall in 2025 was announced following reports of the devices suddenly losing power without warning. The problem was traced back to a faulty electrical component in the MPU.

Problems with heart implants have been linked to dozens of deaths and have sparked a number of HeartMate lawsuits filed in courts nationwide by individuals who suffered serious injuries, or who lost loved ones, due to what they claim is a defective design.

HeartMate 3 LVAD Neurological Risks

For the new study, a group of researchers conducted a retrospective cohort study using data on nearly 12,000 patients who received HeartMate 3 implants from 2017 to 2023. Led by Omar Saeed, the team looked at survival rates, stroke incidence and NEAs.

According to their findings, eight percent of patients suffered a stroke, and another eight percent experienced a nonstroke NEA over a period of 1.4 years. After two years, researchers found that HeartMate 3 recipients faced seven times the risk of death if they suffered a stroke, and more than five times the mortality if they were diagnosed with an NEA. Survival rates for those who had a stroke was only 45%, while those who suffered a nonstroke NEA had a survival rate of about 56%.

Overall, researchers found that nearly one in six HeartMate 3 recipients experienced some form of neurological complication, with approximately half of those events occurring within the first year after implantation.

Among patients who suffered nonstroke neurological complications, 70% experienced problems such as encephalopathy, delirium, seizures or transient ischemic attacks. Another 19% suffered more serious injuries, including bleeding around the brain, oxygen-related brain damage or traumatic brain injuries.

The study also found that patients who suffered bleeding within the brain faced particularly poor outcomes, with only 35% surviving on device support after two years. Researchers identified several factors associated with increased neurological risks, including advanced age, a history of stroke, the use of temporary life-support equipment and additional surgical procedures performed during LVAD implantation.

“Stroke and nonstroke NAEs are incurred by a similar proportion of patients, and both are associated with substantially reduced survival. Consequently, stroke and nonstroke NAEs should be given comparable weight with universal nomenclature when evaluating the safety of durable LVADs.”

– Omar Saeed, Neurological Dysfunction During Contemporary Magnetically Levitated Left Ventricular Assist Device Support for Advanced Heart Failure: An STS-INTERMACS Analysis

Highest mortality risks among nonstroke neurological complications were associated with serious injuries such as bleeding around the brain, oxygen-related brain damage and traumatic brain injuries, which were linked to more than 12 times the risk of death compared with patients who experienced no neurological adverse events.

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