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In May 2018, less than a year after approval, the Federal Food and Drug Administration (FDA) issued a Class I recall on HeartMate 3, a medical device which is inserted into patients to treat heart failure. The device assists in pumping blood in the left ventricle of the heart of patents who are at risk of heart failure.
The HeartMate 3 is intended to be used for short-term support of patients who are at risk of death from end-stage left ventricular heart failure. The device has a blood pump that is implanted in the space around the heart. It contains an outflow graft that connects the pump to the aorta.
The recall is a result of a twisting in the graft that provides blood flow through the device. As a result, the device will issue an alarm to alert patients of low blood flow. This defect in the device could result in hemodynamic compromise, thrombus, and death in patients who received this device.
The recall is a result of thirty-two complaints that the FDA received from physicians. This was out of about 4,900 devices that were implanted since the device was approved by the FDA in August 2017.
The device is manufactured by Abbott. Abbott first learned of the problems in early April 2018, and then announced in early May that they had received information about problems with the HeartMate 3 devices.
A Class I recall means that there is a “situation where there is a reasonable chance that a product will cause serious health problems or death.” Yet the recall does not include plans to remove the device from patients. At this time, doctors were notified by the FDA to closely monitor patients with a transthoracic echocardiograph.
Additionally, if patients are notified of the alarm going off on the device, it is recommended that they receive a CT scan as quickly as possible.
The HeartMate 3 device was originally intended to temporarily assist patients who were waiting for a heart transplant. In an odd turn of events, this recall came only three months after Abbott reported data from its two-year MOMENTUM 3 study of 257 patients who received the HeartMate 3. The study showed that the medical device improved survival and lowered rates of stroke and pump thrombosis.
It is always the hope that medical products will improve the quality of life for patients with little or no harm to the patient. Despite favorable outcomes in the company’s study, the HeartMate 3 has still been recalled and raises cause for concern for recipients of the defective device. If you or someone you know has been hurt by Heartmate3 or another medical device, contact one of our Philadelphia medical device lawyers at Brookman, Rosenberg, Brown & Sandler for a free consultation. Call us at 215-569-4000 or contact us online. We are centrally located in Philadelphia, Pennsylvania, and we represent clients throughout the surrounding areas.