Abbott’s HeartMate 3 Has Another Class I Recall, 2 Deaths Reported

Abbott’s recall of the HeartMate 3 left ventricular assist system (LVAS) implant kit has been deemed Class 1 by the U.S. Food and Drug Administration (FDA).
 
The company recalled the HeartMate 3 LVAS after receiving complaints about blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and apical cuff. The issue was seen during the device’s implantation in all reported events.
 
Blood leakage or air entering the LVAD from this area will impact blood flow integrity, Abbott warned. It may also lead to longer than expected surgery, hemorrhage, right heart failure, or air embolism.
 
So far Abbott has reported 81 incidents, including 70 injuries and two deaths related to the issue. Last month, the FDA named HeartMate 3 in another Class I recall related to extrinsic outflow graft obstruction that was responsible for 14 deaths.
 
However, the company’s March 20 Urgent Medical Device Correction recommended not returning unused product because it’s not being removed from the field.
 
Abbott also advised that if leakage or air is suspected or seen that residual air must be immediately evacuated from the device’s blood chamber before starting LVAD support. Bleeding should be assessed and hemostasis properly managed before closing all wounds.
 
To resolve air leaks or surgical bleeding, the company recommended adjusting pump position, waiting for blood’s natural tendency to coagulate. Upon reversal of anticoagulation, users are advised to add surgical materials and exchange the apical cuff, the pump, or both.
 
A complete backup system (implant kit and external components) should be available onsite and near during HeartMate 3 implantation should an emergency arise.

More about the HeartMate 3 LVAS

The device is used to help the heart pump blood when it can’t effectively on its own. 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.