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A well-known medical device used in patients with heart failure has recently been recalled by Abbott Laboratories, the manufacturer of the HeartMate 3™ Left Ventricular Assist System. Based on information provided by the Food and Drug Administration (FDA), Abbott Laboratories recently issued notifications to physicians about a potentially life-threatening defect associated with the HeartMate 3™ […]
A well-known medical device used in patients with heart failure has recently been recalled by Abbott Laboratories, the manufacturer of the HeartMate 3™ Left Ventricular Assist System. Based on information provided by the Food and Drug Administration (FDA), Abbott Laboratories recently issued notifications to physicians about a potentially life-threatening defect associated with the HeartMate 3™ device. Upon learning of the defect, Abbott did not immediately recall the product but instead provided guidelines to physicians on how to monitor the issue with their patients. Such guidelines are available on the FDA’s recall notice.
However, because there have been multiple patient deaths associated with the HeartMate 3™ pump, as described in one of Abbott’s notifications to physicians, the medical device company finally decided to go forward with issuing a recall of the device. As such, the HeartMate 3™ is now subject to a class I recall, which the FDA states are the most serious type of recall available. A class I recall means that a product is dangerous enough to cause serious injuries or death to patients potentially. Medical device recalls often produce feelings of fear, stress, anxiety, and uncertainty as thousands of patients may wonder if they will experience a severe injury or death because of a product implanted inside their bodies. Therefore, recalls should always be taken seriously, especially when the product at issue is necessary to treat a patient’s chronic condition, such as heart failure.
The HeartMate 3™ Left Ventricular Assist System, manufactured by Abbott Laboratories, is a device that assists in the delivery of blood from a person’s heart to the rest of the body. The device is intended to be used on a short-term basis for patients who are at risk of death from what is called “end-stage left ventricular heart failure.” Such patients are typically on a waiting list to receive a heart transplant. The HeartMate 3™ incorporates a blood pump that is implanted into the space around the heart called the “pericardium.” The device also has what is called an “outflow graft” that connects the pump to the aorta. The HeartMate 3™ is a medical device that many patients rely on to ensure there is proper blood flow throughout the body.
The FDA has provided the following recall information for the HeartMate 3™ Left Ventricular Assist System that is subject to a class I recall:
Because the HeartMate 3™ is a unique product, there are no generic equivalents subject to the same class I recall. Therefore, all patients should confirm with their medical providers whether they have a HeartMate 3™ pump implanted or some other heart device which may not be subject to a recall.
Why Was the HeartMate 3™ Recalled?
Abbott Laboratories decided to recall the HeartMate 3™ Left Ventricular Assist System after they discovered a malfunction in the device’s outflow assembly which may lead to twisting or closing up, which is called “occlusion.” If the outflow graft is occluded, then there is a reduction in the amount of blood flowing from a person’s heart to the rest of the body. The HeartMate 3™ device has a “low flow” alarm that goes off if there is an insufficient level of blood flow. When the outflow graft closes up or “occludes,” the low flow alarm may go off persistently. The outflow assembly is not designed to twist or close up, and because of the recently identified defect in the HeartMate 3™ device where such twisting and occlusion was present, patients with this device are at risk of suffering severe injuries or death.
Abbott Laboratories has provided information to physicians and the medical community about what steps to take for patients who currently have a HeartMate 3™ device implanted. The FDA’s recall notice states that Abbott does not recommend that patients have the device removed, but instead advises patients to check with their healthcare providers to undergo an evaluation. Physicians are instructed to monitor every patient with testing and imaging to ensure the outflow graft is not twisting or closing up/occluding. Because every patient is different, the device may twist and occlude in some patients and not in other patients. However, because the risk of injury or death is substantial enough to warrant a class I recall, all patients should be aware of what steps to take going forward.
Abbott Laboratories is currently aware of thirty-two (32) reports of outflow graft twisting out of 4,467 HeartMate 3™ devices sold worldwide. Twisting of the outflow graft in these thirty-two (32) patients caused the graft to close (occlude), and therefore limit or obstruct the amount of blood flowing from the heart to the rest of the body. So far, three (3) patients have reportedly died because of the HeartMate 3™ device’s defective outflow graft. Reported injuries associated with the HeartMate 3™ pump device include the following:
While Abbott asserts that the complication rate associated with the HeartMate 3™ device is less than 1% of all devices sold, the reported complications are severe enough for Abbott to recall the product. Now that the HeartMate 3 ™ pump is subject to a class I recall, the device cannot, and will not, be sold until Abbott can address the safety concerns associated with the product. Many patients who currently have a HeartMate 3™ pump implanted to treat their heart condition are fearful that the outflow graft on their pump could twist and set off the device’s “low flow” alarm. Living in such fear can be stressful and emotionally painful.
If you currently have a heart condition and have had a HeartMate 3™ pump implanted in you, it is essential that you speak with your doctor about your heart pump to ensure the pump is functioning correctly. While many patients may not experience complications with the HeartMate 3™ pump, it is essential that current patients are aware of what to do if they experience a persistent low flow alarm on their device. Occlusion (closure of the output graft) may cause serious injuries or death. If you have experienced a severe injury, or your loved one has died because of the HeartMate 3™ device, speaking with an attorney about your situation is a good step to take.
When medical devices fail, patients and their loved ones suffer the consequences. If you suffered from low blood flow, blood clots or any other injuries because of the HeartMate 3™ pump or any other medical device, you should consider how a qualified lawyer can help you. At Parker Waichman LLP, our team of nationally-recognized trial attorneys helps their clients receive the compensation they deserve for their pain and suffering.
To speak with a HeartMate 3™ pump claims lawyer about your situation, contact Parker Waichman LLP today by calling (800) YOUR-LAWYER (968-7529) to schedule your free consultation.