According to a May 15 announcement, Abbott is recalling its HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kit for risk of blood leakage or air entering the system between inflow cannula and apical cuff.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The HeartMate 3 Left Ventricular Assist System (LVAS) is used to help the heart pump blood when it is not able to do so effectively on its own. The HeartMate 3 is used for both short- and long-term support in pediatric and adult patients with severe left ventricular heart failure. It can be used while waiting for a heart transplant, to help the heart recover, or as a permanent solution when a transplant isn't an option.
HeartMate 3 LVAS takes over the pumping function of the left ventricle, the main pumping chamber of the heart. It diverts blood from the weakened left ventricle and propels it into the body's main artery, the aorta, helping to circulate blood throughout the body. The device is used both inside and outside of the hospital.
Abbott is recalling the HeartMate 3 LVAS after complaint reviews identified blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff. In all reported events, the issue was observed during implantation of the device.
Blood leakage or air entering the LVAD from this location will impact the integrity of the blood flow and may lead to longer than expected surgery, bleeding (hemorrhage), right heart failure, or air embolism. Use of these devices may cause serious injury or death.
Abbott reports 81 incidents, including 70 injuries and two deaths related to this issue.
