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What To Do If You Have The Medtronic HeartWare HVAD Device

Author
Daisy Rogozinsky
April 5, 2022

For patients with end-stage diseases, medical technology can be a much-needed source of hope and potentially even a lifesaver. But when promising devices thought to be able to change the course of the lives of those with life-threatening diseases turn out not to function as intended, the results can be tragic. 

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If you or a loved one experienced cardiac issues after receiving the Medtronic HeartWare device, we can help you fight for your rights and compensation.

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This was the case with the Medtronic HeartWare HVAD Pump System, a medical device used by patients with heart failure as an alternative to heart transplants. Not long after it was approved by the FDA, cases began to be reported in which the HeartWare HVAD malfunctioned, harming its users. 

Yet the device is dangerous to remove, leaving people with it installed uncertain about how to proceed. In this article, we’ll offer some background on the issues that have been found in the HeartWare HVAD and explain what it means for those who already have the device installed. 

Background on the HeartWare Heart Device

The Medtronic HeartWare HVAD system is a ventricular assist device (VAD), a type of new technology created to help patients with end-stage heart failure who are not candidates for heart transplants. These patients’ hearts’ natural pumping system, the ventricles, don’t perform well, meaning they require additional help to keep blood flowing through the body. The HeartWare HVAD was designed to be able to step in and help the patients’ hearts function normally. 

Purchased by Medtronic from HeartWare International in 2016, the HeartWare HVAD emerged as an incredibly promising treatment option for patients with few other choices. Those with advanced heart failure have very low survival rates, especially if they are unable to receive a heart transplant for one reason or another. With its FDA approval in 2017, the HeartWave HVAD was implanted in thousands of people worldwide, offering a sense of hope about the future. 

Known Issues With the HeartWave HVAD

Unfortunately, it did not take long for people to begin reporting problems with the HeartWave device. As more people received the implant, reports rolled in of serious side effects. Among other issues, patients reported that the device was not successfully syncing with the frequency of their bodies, leading to serious issues like stroke, injury, and even death. Tragically, what was supposed to be a life-saving device proved to, in some, have the opposite effect. 

Even though the FDA responded by putting Medtronic on notice, citing that they were not properly monitoring or repairing defects in the device, the problems persisted. Out of 19,000 people who received the HeartWare device, the FDA received more than 3,000 reports of patient deaths related to the device. 

Although it may have come too late, Medtronic did eventually choose to recall the device, removing it from the open market in June of 2021. They explained that they’d had a problem for at least 12 years in which devices did not restart after being disconnected from power, and even admitted that there was a different competing device that was safer to use. 

Yet this did not necessarily solve the problem, as at least 4,000 people around the world are still relying on the HeartWare device. Of course, this is a scary position to be in. Not only are these patients with advanced heart failure, but the device that they thought would improve their outcomes turned out to not be as safe as they were led to believe. It’s only natural for people with the HeartWave device installed to wonder what they should do next. 

Options for People With the HeartWave Device Installed

While it may seem like the best route is to have the HeartWave device removed, this is not exactly a viable option. The surgery required to remove the HVAD is quite risky, and both the FDA and Medtronic advise against it. The device was designed to be left in place until the patient had a heart transplant. But this is not always an option available to everybody. So what is there left to do?

In terms of medical intervention, the most important thing that you can do is speak to your doctor. They will be the only ones familiar enough with your case to make individualized recommendations.

According to Medtronic, the company wants to do everything possible to minimize risks to your health, including providing ongoing product support, ensuring the continued availability of replacement equipment, and offering a Medtronic Hotline (1-800-635-3930) that you can call with questions about your HVAD device, including financial assistance for certain medical expenses.

Yet despite all of this, it’s quite possible that you might still feel that you are owed some kind of compensation from Medtronic for what they have put you through by selling you a medical device that they themselves later admitted is unsafe. And you wouldn’t be the only one to feel that way.

This is why there have been multiple lawsuits filed against Medtronic, including a mass tort lawsuit that you may be able to join in order to seek both economic and non-economic damages for your pain, loss, suffering, and medical bills.

Find Out If You Are Eligible for Compensation

If you have a HeartWare HVAD device implanted, you could potentially be compensated through the mass tort lawsuit against Medtronic. In order to join this lawsuit, you’ll need to work with a lawyer who will be able to help you navigate through the legal process of filing a claim, managing a trial, and negotiating settlements in order to ultimately receive the compensation you deserve. 

Contact our experienced legal team today to find out if you are eligible to participate in the lawsuit against Medtronic. Our professional lawyers will help you understand if you are eligible and guide you through the legal process to receive the fairest compensation for your suffering. Reach out today for more information.

Free Case Evaluation

If you or a loved one experienced cardiac issues after receiving the Medtronic HeartWare device, we can help you fight for your rights and compensation.

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We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.

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