Parker Waichman LLP is presently investigating potential product liability claims against Medtronic, the manufacturer of the HeartWare HVAD System for injuries and death suffered by heart patients. The Food and Drug Administration (FDA) recently issued a Class I recall of the HeartWare device because of malfunctions that have been linked to unnecessary injuries and deaths. If you have sustained injuries you believe to be related to the HeartWare device, or if your loved one has sustained fatal injuries associated with the device, you may be entitled to compensation on behalf of yourself or your loved one.
What is the Medtronic HeartWare HVAD System?
Patients suffering from life-threatening heart failure, many of which are waiting for heart transplants, must rely on medical devices to help them survive. One such device is called the HeartWare HVAD System, manufactured by Medtronic. While the HeartWare device has been helpful in keeping many heart patients alive while they wait for a transplant, the device has experienced recent failures that can pose a serious risk of harm or even death to patients. The HeartWare device includes a variety of components that must function together without interruption. When one part of the device fails to work properly, the entire device cannot function as intended.
The Medtronic HeartWare HVAD System includes the following components, as shown in the image below:
- HVAD Pump;
- Battery; and
- AC Adapter.
The Medtronic HeartWare HVAD System is typically used in hospitals but has also been used when transporting patients by helicopter or plane. In such cases, the HeartWare device is likely being used to keep a patient alive who is awaiting a heart transplant. However, the HeartWare device is also used with patients who are undergoing myocardial recovery or destination therapy.
Food and Drug Administration (FDA) Issues Class I Recall for Medtronic HeartWare HVAD System
The Food and Drug Administration (FDA) issues public health and safety notifications when a drug or medical device has proven to be potentially dangerous or life-threatening. Medtronic’s HeartWare HVAD System is now subject to a Class I recall, the most serious of recalls available. The FDA issued the Class I recall on May 2, 2018, stating that the Medtronic HeartWare HVAD System poses a risk of injury or death to patients. The following information outlines specifications of the HeartWare device that all patients and physicians should know about:
- Product Name: Medtronic HeartWare HVAD System (includes all devices that have been used over the past twelve (12) years, totaling more than 200,000 devices)
- Model Numbers
- Controller and Controller Kits: 1400, 1401, 1403, 1407, 1420
- DC Adapter: 1435, 1440
- AC Adapter: 1425, 1430
- Battery Pack: 1650
- Serial Numbers: All
- Manufacturing Dates: March 2006 to May 2018
- Distribution Dates: March 2006 to May 2018
- Total Number of Devices Recalled in the United States: 204,017
Why is the HeartWare HVAD System Subject to a Class I Recall?
Medtronic voluntarily recalled the HeartWare HVAD System when it discovered that interruptions in the electrical connection of the device have caused the device to stop working suddenly. The reason for such interruptions is the development of oxidation along the connecting surfaces between the controller’s power source socket and the power source connector, according to both Medtronic and the FDA. What this means is that the HeartWare device could suddenly stop working and prevent adequate blood flow from pumping from the heart to the rest of the body. When interruptions happen, the device may make a persistent and unexpected audible tone that signals something is wrong. Power interruptions in a device as important as the HeartWare HVAD System have the potential to cause a person to sustain serious injuries or death.
FDA Recommendations for Heart Patients and Doctors
When the FDA issues safety alerts for specific dangerous pharmaceutical drugs or medical devices, it always provides guidance and recommendations to patients and doctors. Because many patients do not monitor FDA safety alerts, it is imperative that doctors are fully aware of up-to-date information regarding the safety of a product. The FDA safety notice regarding the Class I recall of the HeartWare device identifies various recommendations given by Medtronic that were listed in a letter sent to healthcare providers (including doctors and hospitals) in May of 2018.
Such recommendations include the following:
- Make sure two power sources to the HeartWare device are connected at all times;
- Make sure both healthcare professionals and patients follow best practice guidance when monitoring power sources when going to sleep and waking up; and
- Make sure patients are instructed to report any persistent or unexpected audible tones emitted from the device to their healthcare providers and await further guidance.
In most cases, a patient using the HeartWare device will be under the supervision of a healthcare provider, whether in a hospital setting or during transport from one facility to another. However, when a patient is using the HeartWare device at home, it is imperative that the patient has another person at home to ensure the above-listed recommendations are being followed. Because many patients rely on the HeartWare device for serious and debilitating heart-related conditions, they may be unable to follow Medtronic’s recommendations without the help of another person.
Finding Out if You Have a Potential Medtronic HeartWare HVAD System Lawsuit
It is not always easy to determine if a particular pharmaceutical drug or medical device has caused a person to sustain injuries or death. As such, a lawyer investigating potential Medtronic HeartWare HVAD System Lawsuits will evaluate a client’s situation to determine (1) if the client was using the HeartWare system under the care and direction of a healthcare provider, and (2) if the client suffered one or more of the following injuries:
- Worsening of heart failure symptoms;
- Loss of consciousness; and
Potential lawsuits involving the HeartWare device can be complicated, especially because heart patients are already weak from their underlying condition. Therefore, patients and their loved ones who believe they have a valid HeartWare HVAD System Lawsuit should consider working with a lawyer who is well-versed in handling defective pharmaceutical drug and medical device lawsuits.
Not only are a client’s injuries and reliance on the HeartWare device important, but a lawyer will also want to determine if a client still has time to file a lawsuit. All states have laws that limit how much time a person has to pursue a legal claim. If this time limit expires, an injured client may never have a chance to receive compensation for his or her suffering. By moving quickly to consult with a lawyer about a potential HeartWare HVAD System Lawsuit, injured clients are taking a step to protect their legal rights and interests.
Parker Waichman LLP – Obtaining More than $2 Billion in Compensation for Clients
Parker Waichman LLP is a well-known law firm that routinely handles a variety of personal injury matters including, among others, defective pharmaceutical drugs and medical devices, medical malpractice, workplace accidents, slip and fall accidents, auto accidents, and construction accidents. Because the Personal Injury and Product Liability Lawyers of Parker Waichman LLP have been successful in obtaining more than $2 billion in compensation collectively for their clients, our firm has received numerous positive peer-reviewed ratings that include, among others, the following:
- 9.8/10 Rating by AVVO;
- “Preeminent Lawyers” AV Rating by Martindale-Hubbell;
- Ranking of “5 Dragons” by Lawdragon (the highest ranking available); and
- Listing in “Best Lawyers” Publication Established by Thorough Peer Review.
Parker Waichman LLP also has a track record of providing compassionate and quality customer service to clients. Our firm’s goal is to not only receive the maximum compensation possible for injured and deceased clients but also to ensure the legal process runs as smoothly as possible. With the help of Parker Waichman LLP, our clients have peace of mind that their legal claim is being handled by a highly skilled and dedicated law firm.
Contact a Medtronic HVAD System Lawsuit Attorney to Schedule Your Free Consultation
If you believe you have a potential Medtronic HeartWare HVAD System Lawsuit, you should consider speaking with a highly experienced lawyer right away. At Parker Waichman LLP, our nationally-recognized trial lawyers will evaluate your potential claim to determine if compensation may be available. Contact us today by calling (800) YOUR-LAWYER (968-7529) to schedule a free consultation.
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