Abbott HeartMate 3 Lawsuit Alleges Pump Failure Led to Man’s Death

Manufacturers issued a HeartMate 3 pump recall notice only one month after the man’s death, due to similar reports of flow problems caused by blockages.

The family of a Texas man has filed a product liability lawsuit against the makers of the HeartMate 3, saying the heart pump’s defective design led to his death.

The complaint was originally brought in California Superior Court in late January 2026, and subsequently removed (PDF) to the U.S. District Court for the Northern District of California on February 25. Filed by Julie, Emily and George Rodriguez on behalf of the estate of Renne Rodriguez, the lawsuit names Thoratec Corporation, Sum Thunder Holding Company and Abbott Cardiovascular as defendants.

The HeartMate Left Ventricular Assist System, or LVAD, is an implantable medical device used to help patients with advanced left ventricular heart failure circulate blood throughout the body. The system includes a surgically implanted heart pump that is controlled and monitored by an external controller, which is powered by a HeartMate Mobile Power Unit when the patient is away from a stationary power source.

HeartMate LVAD Pump Problems

Over the past few years, the device has been plagued with problems, patient injuries and deaths, which have resulted in a number of different recalls and safety warnings since the HeartMate LVAD was first introduced in 2001.

As recently as April 2025, the FDA announced a HeartMate 3 and Heartmate II recall, following reports of the devices suddenly losing power without warning. The problem was traced back to a faulty electrical component in the MPU. 

That followed a prior HeartMate 3 recall issued in May 2024, after reports of blood leaks and air embolisms, which increased the risk of hemorrhaging, stroke and heart failure. Leaks in the inflow cannula were found to compromise the device’s ability to circulate blood properly, often requiring emergency surgery.

At that time, the agency indicated the manufacturer had become aware of at least 81 incidents of blood leaks or air entering the devices, resulting in 70 injuries and two deaths linked to the HeartMate 3.

In previous years, the HeartMate II and HeartMate 3 accessories have been subjected to several other recalls over battery backup failures, controller communication errors and biological material buildup. These issues have been linked to hundreds of HeartMate LVAS obstruction problems and at least 14 deaths.

The Rodriguez’s wrongful death lawsuit now joins a number of similar HeartMate 3 recall lawsuits being pursued on behalf of individuals who suffered serious injuries, as well as by families who allege they lost loved ones due to defects or malfunctions involving the HeartMate devices.

According to the lawsuit, Renne Rodriguez was implanted with a HeartMate 3 device in November 2023, due to advanced heart failure. The LVAD was intended to help maintain continuous blood circulation and serve as a life-sustaining therapy.

However, his family, including his wife Julie and their two children, Emily and George, allege that the manufacturers knew for years that the HeartMate 3 was defective before it was implanted in Rodriguez. They claim the companies were aware of numerous reports of device problems and had already issued multiple recalls and safety corrections.

The lawsuit alleges that Abbott was aware of flow disruptions associated with the device but failed to properly report those issues to the FDA or take timely corrective action. According to the complaint, Rodriguez’s HeartMate 3 later experienced the same type of outflow obstruction, which the family claims ultimately led to his death on January 17, 2024.

Less than one month after Rodriguez’s death, the defendants began notifying customers about reports of obstruction involving the HeartMate 3 outflow graft.

“On February 14, 2024, Defendants began sending letters to customers warning of the risk that the outflow graft on the HeartMate 3 had been reported to be obstructed and this posed a risk of serious injury and death.”

– Julie Rodriguez et al v. Thoratec Corporation et al

The letter indicated that the problem was caused by a buildup of biological material between the outflow graft and the outflow graft bend, leading to loss of blood flow and potentially death. The FDA later classified the recall as Class I on March 22, 2024, its most serious designation, indicating a reasonable probability that the defect could cause serious injury or death.

The Rodriguez family presents claims of negligence and failure to warn, alleging that earlier corrective action or adequate disclosure may have prevented his death.

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