Abbot Recalls HeartMate 3 Left Ventricular Assist Device Over Possible Malfunction Risk

Abbott Laboratories, a world-renowned health care medical technology company, has issued a recall for the HeartMate 3 Left Ventricle Assist Device. The heart device has been used extensively at the Cleveland Clinic and University Hospitals to assist patients with heart failure issues.

As Abbott has informed doctors and medical professionals worldwide, the problems associated with the HeartMate 3 can potentially lead to significantly reduced blood flow or clotting.

The company’s press release reveals its knowledge of three deaths potentially connected with outflow graft twisting of the device. The recall covers heart devices manufactured from 2014 onward, constituting close to 5,000 units in total. The total number of device malfunctions worldwide is 32. At present, none of the devices are being taken from hospitals or patients. Instead, the recall involves an updating of the labeling and instructions for using the heart device.

Function of the HeartMate 3

Patients with serious left ventricle heart failure have benefited from the HeartMate device, which is designed to help the damaged organs pump blood in a more effective manner. Many patients awaiting a heart transplant have this device implanted as a temporary measure. The device consists of a blood pump attached to the aorta with an outflow graft.

FDA labels the recall Class I

The FDA designated the HeartMate 3 recall as a Class I recall, which means it is the highest form of recall in terms of the potential of the device to cause serious injury or death to the patient.

According to the FDA, the recall is in effect due to the potential for the outflow graft assembly to malfunction which can precipitate the outflow graft to twist and completely constrict over time. The effect would result in severely hindered or stalled pump flow and a recurring low flow alarm. If this occurs, the HeartMate 3 would then be functioning as a dangerous medical device with reduced pumping leading to potential blood clots and death.

Effect of the recall and FDA recommendations

A total of 4,878 units in the U.S. are affected by the recall. The specifically affected products have catalog numbers 106524, 106524US, and 10652INT. According to the FDA, the recall covers all manufacturing dates and lot numbers for HeartMate 3 devices disseminated between September 2, 2014 and the current date.

Patients who experience a recurring low flow alarm should immediately contact the doctor who is managing their HeartMate 3 device. The manufacturer is not recommending removal of the device.

According to the FDA, patients with the device should obtain an echocardiogram to evaluate the device’s operation. Surgery may be required to fix the device.

Abbott Laboratories began the process of notifying HeartMate 3 patients about the issue in April 2018. At that time the company provided up-to-date guidelines for physicians implanting these devices as well as patients who currently have the device.

If you have experienced an injury due to a defective medical device, our experienced trial attorneys at McGowan, Hood, Felder & Phillips, LLC are here to help you obtain the financial recovery you deserve for your pain, suffering, and other losses. Let’s discuss your case together and go over your legal options. To set up a free, initial consultation with an experienced medical device attorney from our team, call us today at 803-327-7800 or simply fill out our contact form.