Medical Device Manufacturer Abbott Subject of Recall Heartmate 3 Left Ventricular Assist System Recall
The U.S. Food and Drug Administration (FDA) issued a Class I recall notice for Abbott’s Heartmate 3 left ventricular assist device (LVAD) due to problems with the outflow becoming blocked. The blockage, or occlusion, can substantially reduce or prevent blood flow from the left ventricle to the aorta. The occlusion appears to the result of a design flaw with the Heartmate 3.
An occlusion is a potentially lethal malfunction. Accordingly, the FDA issued a Class I recall for the device. A Class I recall is the most urgent recall notice issued by the FDA. A Class I recall means that a device malfunction could lead to death or severe illness. Incredibly, Abbott has not mandated that people who rely on the LVAD have it replaced. Instead, Abbott wants people to take a wait-and-see approach.
Parker Waichman LLP is a nationwide plaintiffs law firm who has dedicated, accomplished, and skilled medical device defect lawyers ready to aggressively pursue the maximum recovery for your claim. Our clients who were injured by “global” pharmaceutical manufacturers like Abbott feel like their lives are insignificant to these huge companies. While losing a loved one to a defective medical device devastates a family, it is just the cost of doing business for Abbott and companies like Abbott. The loss of one life to a fault medical device is unacceptable to our product liability lawyers. That is why we stand up to large drug companies. Our clients found a measure of justice and peace knowing that they chose our firm to lead the charge against companies like Abbott and recover the compensation they deserved for their loss.
Why Did the FDA Recall Abbott’s LVAD?
Understanding why the FDA issued a Class I recall requires a discussion about the mechanics of the Heartmate 3 LVAD. Abbott designed the Heartmate 3 to enhance the quality of life, and even increase the longevity, of a person suffering from end-stage heart failure. End-stage heart failure is a dire diagnosis. End-stage heart failure means that the person’s heart cannot pump oxygenated blood through the heart and into the body. Abbott’s Heartmate 3 assists the heart by facilitating the left ventricle pump the blood. Without it, death could be imminent. Thus, people who have these devices implanted within them are fighting for every last breath.
Abbott’s LVAD is a system that is attached to the left ventricle of the heart. An outflow tube acts as a conduit between the heart and the aorta. The graft, or connection, is the gravamen of the issue here. Heart surgeons connect the tube from the ventricle to the aorta by a grafting procedure. The pump sends the blood to the aorta. A controller which the patient wears on the outside of their body, along with battery packs, monitors the pace at which the pump allows the blood to flow. A surgically inserted cable runs from the pump to the controller on the outside of the body. Doctors call this cable the “driveline.”
Abbott’s LVAD has three uses. The first use is as a “bridge therapy.” In essence, the pump bridges the gap between heart failure and a heart transplant. The second use is as a “destination therapy.” That means the patient is not scheduled to receive a heart transplant but whose heart is functioning with the assistance of the LVAD. People can thrive for a long time with this device as the technology continues to improve. The third use is as a “bridge to recovery.” In this scenario, the person needs the LVAD to recuperate from temporary heart failure due to an injury or illness. The patient expects the heart to regain full strength eventually. Therefore, using an LVAD as a bridge to recovery is only temporary. The critical aspect that medical device manufacturers must consider is that no matter why a person needs that device, they all need it to continue to live.
With that background, it is plain to see why the FDA became so concerned about the LVAD malfunction to announce a Class I recall. When the graft becomes occluded, a low blood flow monitor sounds a warning. The defect, according to the FDA, lies within the graft assembly. In other words, Abbott’s LVAD suffers from a defective design. This flawed design causes the grafting tube to twist. Once twisted, the graft will slow and eventually block the flow of blood.
The twisted graft can have devastating consequences. The patient experiencing reduced blood flow could suffer from blood clots or cardiac arrest. Either situation can kill the patient.
The FDA sent two communications to Abbott expressing its concern about the graft occlusion problem inherent in the LVAD. Only after the second communication did Abbott agree to issue a recall notice. Abbott’s recall notice did not order the removal of the potentially lethal device. Instead, they counseled physicians to monitor their patients closely and perform radiographs like echocardiogram tests to examine the blood flow from the left ventricle to the aorta. Abbott’s suggested protocols further suggested that doctors should continue to submit their patients to testing procedures like CT scans until all other possibilities for the LAVD emitting the low blood flow alert.
Once surgeons ruled out every other possibility, then Abbott suggests, the cause of the low blood flow alarm is a twisted graft blockage. Resolving the twisted graft blockage requires additional surgery. At this point, the patient’s health is substantially compromised. Surgeons must remove the twisted tube and reattach it to increase blood flow.
Subsequent surgeries are complicated for anyone, especially a person with end-stage heart failure. Any surgery carries the threat of blood loss, blood clotting, adverse effects from anesthesia, coma, and death from the trauma of the surgery itself.
Turn to Parker Wacihman LLP for Help if You or a Loved One has a Heartmate 3 Left Ventricular Assist System Occlusion
Parker Waichman LLP has an unparalleled track record of holding medical device manufacturers responsible for their defective medical devices. To date, Parker Waichman LLP has recovered over $2 billion in damages for their clients. A law firm does not experience that degree of success unless its attorneys are willing to do whatever is required to ensure that their clients get all of the compensation for which they are eligible.
Our medical device defect lawyers have extensive experience negotiating with insurance companies and taking on the large, powerful, and influential law firm companies as Abbott hire. Additionally, our lawyers have access to numerous expert witnesses who can evaluate your situation and render an opinion that will help prove your case. Finally, we have tremendous financial resources to which other law firms do not have access.
We work on a contingent fee basis. That means we will never ask you to put up any money out of your pocket for costs of litigation or to retain our services. We do not get paid unless you get paid.
The time to file is now
Any delay in filing your claim for a defective Heartmate 3 left ventricular assist system could damage the strength of your claim. Do not let this happen to you. Call Parker Waichman LLP today to arrange a complimentary, no-obligation case review. Our Heartmate 3 lawyers will thoroughly examine the facts of your case, your economic damages such as medical bills, as well as your mental anguish, along with your pain and suffering.
Call Paker Waichman LLP’s Heartmate 3 lawsuit attorneys today to schedule a free case evaluation. Call 1-800-YOURLAWYER (1-800-968-7529) to schedule your consultation today. We are here 24/7 for you and your family.
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