14 Deaths Connected to Latest Abbott HeartMate Recall

A life-saving heart pump that has helped more than 30,000 people worldwide live longer, more active lives is now the subject of a serious recall.

Abbott is recalling its HeartMate II and HeartMate 3 left ventricular assist systems due to a problem called extrinsic outlflow graft obstruction that has been linked to 273 reported injuries and 14 deaths.

The graft obstruction is 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 that the recall, which Abbott initiated on February 19, is considered a correction, not a product removal. In an urgent medical device correction letter, sent to all affected customers, the company asks customers to pay attention to low-flow alarms as this is the first symptom of significant outflow obstruction.

This recall comes about a month after Abbott recalled the HeartMate Touch Communication System that monitors HeartMate 3 patients.

The HeartMate devices were developed by Thoratec, which St. Jude Medical bought in 2015 for $3.4 billion. Later, Abbott inherited the technology through its $25 billion acquisition of St. Jude Medical.

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.

The video below, courtesy of Abbott, shows how the HeartMate 3 works, how mechanical heart pumps have evolved over time through research and development, and how the device offered "new hope" to one patient.