Customers of an Abbott heart pump have reported 81 incidents, 70 injuries and two deaths related to blood leakage or air entering the device, according to the FDA.
The company's HeartMate 3 Left Ventricular Assist System is used for short- and long-term support in patients with severe left ventricular heart failure, and can be used while waiting for a heart transplant or to help the heart recover.
All customer reports have said the issues happened during implantation between the inflow cannula and the apical cuff. Blood leakage or air entering between these components can hinder "blood flow and may lead to longer than expected surgery, hemorrhage, right heart failure or air embolism," the FDA said. "Use of these devices may cause serious injury or death."
Abbott instructed customers to follow standard surgical processes and the device's instructions for use. This notice is a product correction notice, not a product removal.