This Medical Device Has a Scary History

Back in 2014, MD+DI published a list of the scariest medical devices of that year. Topping the list was Thoratec's HeartMate II left ventricular assist device (LVAD).

Interestingly enough, the problem at that time had nothing to do with the LVAD itself, but user error due to not understanding instructions and lacking the training needed to hook up a backup system controller in cases of device alarm or malfunction.

Nevertheless, the problem resulted in four patient deaths and caused five other patients to lose consciousness or experience reduced blood flow.

FDA explained at the time that all reports were linked to patients whose HeartMate II device was originally attached to an older model of controller. When a new controller became available, patients were switched to the new controller but did not receive intensive training on connecting the new controller.

Fast forward 10 years, and the HeartMate 3, which Abbott inherited through its acquisition of St. Jude Medical (St. Jude acquired Thoratec in 2015), has been the subject of multiple recalls.

The life-saving heart pump, which has helped more than 30,000 people worldwide live longer, more active lives has now been linked to at least 273 injuries and 14 deaths.

Abbott recalled its HeartMate II and HeartMate 3 left ventricular assist systems due to a problem called extrinsic outlflow graft obstruction caused by longterm buildup of biological materials between the outflow graft and the outflow graft bend of HeartMate systems.

Typically, it takes buildup of more than two years to cause such an obstruction in the device. An obstruction makes the device less effective in helping the heart pump blood, according to an FDA notice tagging the HeartMate recall as a class I recall, the most serious type. FDA noted, however, that the recall was a correction, not a product removal.

Abbott asked customers via an urgent medical device correction letter to pay attention to low-flow alarms as this is the first indication of significant outflow obstruction.

How the HeartMate systems work

The HeartMate II and HeartMate 3 are used for both short- and long-term support in adult patients with severe left ventricular heart failure. The technology can be used as a bridge-to-transplant therapy for patients waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant is not an option. HeartMate 3 can also be used in pediatric patients.

The HeartMate devices are designed to take over the pumping function of the left ventricle, the main pumping chamber of the heart. They divert blood from the weakened left ventricle and propel it into the aorta, helping to circulate blood throughout the body.