About 6.2 million adults have heart failure in the United States. Heart failure happens when the heart cannot pump enough blood to support other organs. In cases of heart failure, some patients seek a heart transplant, but these can be difficult to receive. More than 3,500 Americans are waiting for a heart transplant. Unfortunately, many will die before a heart is ever available. Some people may receive a heart failure device to tide them over until a transplant. However, Medtronic’s HeartWare Ventricular Assist Device (HVAD) may cause devastating injury or even death. Did you or a loved one suffer injuries due to a HeartWare Ventricular Assist Device? Reach out today to learn more about how a HeartWare Ventricular Assist Device lawsuit can benefit you.
Our law firm is currently handling lawsuits on behalf of individuals harmed by HeartWare Ventricular Assist Devices.
American medical device manufacturer Medtronic debuted its HeartWare Ventricular Assist Device (HVAD) in 2012. The HVAD helps patients with end-stage heart failure awaiting a heart transplant. Patients with end-stage heart failure endure several debilitating symptoms, such as shortness of breath, fatigue, ulcers, poor circulation, and fluid buildup. The HVAD prolongs and improves a patient’s life by providing additional blood flow.
The HVAD consists of a pump implanted around the heart, tubing to drain and pump blood, and a controller. Medical professionals use the controller to regulate the speed and function of the pump.
In June 2021, Medtronic announced it would no longer manufacture or distribute the HVAD. Medtronic arrived at this decision following reports of adverse neurological effects and mortality linked to the pump. Additionally, the pump can stop and may not restart. At the time of the June 2021 recall, Medtronic reported that it received over 100 complaints regarding the HVAD device, including 14 deaths and 13 pump removals.
The FDA placed the HVAD recall in its Class I category. Class I is the FDA’s most serious type of recall. The agency warns Class I devices may result in injury or death for the user. Furthermore, the FDA instructed healthcare providers to stop implanting Medtronic HVAD systems and to use alternative devices for heart failure patients.
However, the problems did not stop after this first recall. In April 2022, Medtronic announced that HVAD patients who present with pump thrombosis may have a weld defect in the internal pump of the HVAD, causing it to malfunction. The company stated that three patients exchanged their HVAD systems following suspicion of pump thrombosis. Two out of the three that received pump exchanges died. This prompted Medtronic to recall a single lot of HVAD batteries due to the welding defect. The FDA classified this as another Class I recall. Furthermore, in June 2022, recalled additional HeartWare HVAD System batteries because the batteries may experience electrical faults that cause them to unexpectedly fail.
While Medtronic has ceased distribution of its HVAD, the FDA announced that the company released a software fix for the malfunctioning systems. The FDA noted that a backup controller with modified software is available upon request for hospitals. Medtronic designed this backup controller to take over if the pump has stopped and the primary controller fails to restart it. However, Medtronic noted in its letter to healthcare providers that the software is not approved and there is only limited testing behind it. Medtronic advised physicians that this software is only a last resort if the pump fails as the company is unsure of the software’s guaranteed performance or impact on other control functions. This update provides little solace or reassurance to patients who still have an unpredictable HeartWare Ventricular Assist Device.
Patients awaiting heart transplants or those too weak to receive a transplant relied on the HVAD to support their hearts. However, power failures and delayed restarts resulted in catastrophic injuries and death for many patients. Individuals with a malfunctioning HVAD may suffer:
Over 4,000 people worldwide still had a Medtronic HVAD when the company pulled it from the market in 2021. The Medtronic HVAD is riddled with several problems such as weld defects, battery malfunctions, translation issues, and pump failures. Lawsuits allege that Medtronic’s faulty design and manufacturing jeopardized the already fragile health of hundreds of heart failure patients. Plaintiffs argue that multiple people have tragically died due to defective HVAD systems. Moreso, the HVAD systems worsened the condition of countless heart failure patients and only served to further injure them.
If a defective HeartWare Ventricular Assist Device caused you or a loved one harm, you may qualify for an HVAD lawsuit. A HeartWare Ventricular Assist Device lawyer can help you recover compensation for:
Continuous recalls plague Medtronic products. The FDA posted 13 Class I recalls of Medtronic devices from 2021 to 2022. Yet, the medical device company continues to design and manufacture defective products that may cause severe harm to patients and even produce fatal outcomes. If a HeartWare Ventricular Assist Device injured you, you deserve to take action. The issues related to Medtronic’s HVAD systems have spurred multiple Class I recalls and resulted in the deaths of numerous patients. Even though Medtronic ceased distribution of the HVAD, thousands of patients who still have the device are still at risk. Contact us today to speak with an attorney at The Lake Law Firm about filing a HeartWare Ventricular Assist Device lawsuit.
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 525-3529 or submit an inquiry on this page.
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