HeartMate II Wrongful Death Lawsuit Claims LVAD Implant Caused Thrombosis

Complaint joins a growing number of HeartMate lawsuits and recalls referencing alleged device defects linked to serious complications and fatal outcomes.

A wrongful death lawsuit alleges that a defectively designed HeartMate II left ventricular assist device (LVAD) caused dangerous blood clots to form due to an obstruction in the device’s outflow graft.

The complaint (PDF) was brought by Chevi Parker, individually and on behalf of all wrongful death beneficiaries, in addition to the estate of Laura Parker. It was filed in the U.S. District Court for the Northern District of Texas on April 13, naming Thoratec LLC, SJM Thunder Holding Company and Abbott Laboratories as defendants.

Chevi Parker alleges that Laura Parker’s HeartMate II implant, intended to support her declining cardiac function due to advanced heart failure, instead posed an unreasonable risk of thrombosis.

HeartMate LVAD Pump Problems

A HeartMate II LVAD is a surgically implanted mechanical pump designed to help circulate blood from the left ventricle to the rest of the body in patients with severe heart failure. While the device is often used as a bridge to transplant or as long-term therapy, it requires careful management due to the risk of complications.

In recent years, various HeartMate LVAD system designs have been linked to a series of safety concerns, including reports of device malfunctions, patient injuries and deaths. These issues have prompted multiple recalls and regulatory warnings since the product was introduced in the early 2000s.

In April 2025, federal regulators issued a HeartMate 3 and HeartMate II device recall after reports indicated the pumps could abruptly lose power without warning. Investigators traced the issue to a defective electrical component within the system’s motor power unit.

That action followed a May 2024 recall involving the HeartMate 3, which was associated with blood leaks and air embolisms that increased the risk of stroke, hemorrhage and heart failure. The problem was linked to defects in the inflow cannula, which impaired proper blood circulation and, in some cases, required emergency surgical intervention.

At the time, the manufacturer had identified at least 81 incidents involving leaks or air entering the device, which were tied to 70 reported injuries and two deaths.

Earlier recalls have also impacted HeartMate II and HeartMate 3 components, including issues involving battery failures, controller malfunctions and buildup of biological material. These problems have been associated with hundreds of obstruction-related complications and at least 14 deaths.

As a result, a growing number of HeartMate lawsuits have been filed in recent years, including cases brought by patients who experienced serious complications and by families alleging that device defects contributed to fatal outcomes.

HeartMate II Thrombosis Allegations

According to the complaint, Laura Parker underwent implantation of a HeartMate II LVAD to treat severe heart failure. Following the procedure, she allegedly developed complications consistent with pump thrombosis, including impaired blood flow and signs of device dysfunction.

The lawsuit claims the device’s design allowed for abnormal blood flow patterns and accumulation of biological material within the system, increasing the risk of clot formation and outflow graft obstruction. These conditions allegedly interfered with the pump’s ability to circulate blood effectively and contributed to a cascade of life-threatening complications.

Despite medical intervention, the complaint indicates the obstruction and resulting thrombosis ultimately led to fatal consequences. It alleges the device failed to perform as safely as intended and directly contributed to Laura Parker’s death.

The lawsuit further claims the defendants failed to adequately test the HeartMate II prior to its release, identify and correct design flaws, and provide sufficient warnings about the risk of thrombosis and outflow graft obstruction. The filing also states the device was not manufactured in compliance with federal safety requirements, including quality system regulations and design validation standards, rendering it nonconforming and unreasonably dangerous.

In addition, the complaint alleges the defendants had prior notice of similar complications through adverse event reports, clinical data and regulatory findings, yet failed to take appropriate corrective action. This should have included addressing known issues involving the outflow graft bend relief and related components.

“Well before Decedent’s death, Defendants had actual and/or constructive notice of serious quality-system deficiencies and complaint trends involving HeartMate devices and, specifically, the outflow graft bend relief and related system components.”

— Chevi Parker et al v. Thoratec LLC et al

The case raises allegations of negligence, strict liability, manufacturing defect, failure to warn and breach of implied warranty. It seeks damages for wrongful death, including loss of companionship, emotional distress, medical expenses and other losses.

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