Medtronic has announced it will remove its HeartWare Ventricular Assist Device (HVAD) System, a heart failure device, from the market due to its risks of strokes and deaths. The Dublin, Ireland-based company has also notified doctors to cease new implants of the HVAD System and use other products instead, such as the Abbott Heartmate 3 Left Ventricular Assist System (LVAS).
On June 3, 2021, Medtronic, which is among the largest manufacturers of medical devices in the world, issued a statement that said they will halt the manufacturing and distribution of the HVAD System. The letter read that research indicated that neurological issues and fatalities were more common with the HVAD System as compared to other durable left ventricular assist devices (LVADs). The U.S. Food and Drug Administration (FDA) is also telling doctors to stop implanting heart failure patients with the HVAD System because of the greater frequency of neurological adverse events and mortality.
Medtronic Products and Recalls
Over the past 10 years, Medtronic has issued at least 13 recalls involving defects and malfunctions. In some cases, the HVAD may delay or fail to restart, which may worsen the patient’s heart condition, cause them to have a heart attack, require hospitalization, and even result in death. Medtronic, which has its operational headquarters in Fridley, Minnesota, halted sales after analyzing 100 reports of power failures with the device. This led to 14 patient fatalities and 13 patients having it removed. Medtronic had previously issued recalls on other HeartWare devices and components. In December 2020, Medtronic warned about power failures and delayed restarts.
The HVAD System, which is a mechanical pump that moves blood for patients with heart failure, first received FDA premarket approval in 2012. The product pumps blood from the heart to the rest of the body for patients who are waiting for a heart transplant and at risk of dying from heart failure. Approximately 2,000 patients in the United States have the device implanted.
Medtronic said patients should not rush to have the device removed. Removing the implant needs to be carefully weighed against the risks of surgery. Medtronic said doctors should decide on a case-by-case basis, taking into account each patient’s health conditions and surgical risks.
What Makes Up the HVAD System?
Medtronic’s HeartWare Ventricular Assist Device (HVAD) System includes the following components:
- HVAD Pump
- AC Adapter
While the HVAD System is usually used in hospitals, it has also been used when transporting patients by plane or helicopter. In these cases, the HeartWare device is typically used to keep a patient alive while they are waiting for a heart transplant. The device was commonly used for heart failure patients who were waiting for transplant or patients who needed a permanent implant because they were not healthy enough for the procedure. The device was designed to help strengthen the heart’s lower chamber that is necessary for blood circulation.
If you have been injured or a loved one has tragically lost their life due to this defective Medtronic HVAD system, you may be entitled to financial compensation. You may have a claim to recover for medical expenses, lost wages, funeral expenses, and other losses. OnderLaw, LLC is ready to help. Call us now for a free, no-obligation consultation, during which we can explain your rights and discuss all your legal options.
Why Choose OnderLaw, LLC?
Medical device companies have a duty to make sure their products are safe. When a company puts profits over people, innocent people get injured or lose their lives. Many times, it’s not until the threat of major litigation when a company decides to recall defective and dangerous products.
At OnderLaw, LLC, we fight back against large and powerful corporations that have caused innocent people harm. Our highly skilled and experienced defective medical device lawyers have secured compensation for clients all throughout the country. We have held liable corporations accountable for their dangerous products. Our firm has represented clients following numerous recalls, and we have built a reputation nationwide for our success in litigating these cases.
When we evaluate your Medtronic HeartWare HVAD System case, we will determine whether you (1) were using the system under the direction of a doctor or another health care provider, and (2) suffered one or more of the following injuries:
- Worsening of heart failure symptoms
- Neurological dysfunction
- Loss of consciousness
Potential lawsuits involving this device can be complex, especially because heart patients are already weak from their underlying condition. Thus, patients and their loved ones who believe they have a valid claim should consider consulting with an attorney who is experienced in handling complicated defective medical device lawsuits.
The experienced lawyers at OnderLaw, LLC will be able to determine if you still have time to file a lawsuit. All states have time limits on how long an individual has to pursue a legal claim. This is known as the statute of limitations. If the deadline passes, you may never have a chance to recover compensation for your suffering. This is why it’s critical that you act fast and talk with our attorneys about a possible lawsuit against Medtronic as soon as you can. Allow the highly skilled and compassionate defective medical product attorneys at OnderLaw, LLC to take the necessary steps to protect your rights and interests.
Contact a Medtronic HVAD Lawsuit Attorney
If you believe that this Medtronic device has harmed you, the defective medical device lawyers at OnderLaw, LLC are prepared to do everything we can to help you recover the compensation you need and deserve. We are accepting HVAD-induced injury cases in all 50 states. Contact OnderLaw, LLC today by calling (314) 963-9000 for a free and confidential consultation.