Abbott earlier this month warned physicians about a potential communication problem with its HeartMate 3 implantable cardiac pump.
In a June 7 letter, Abbott said it received “limited” reports of communication errors between the HeartMate 3’s system controller and the pump itself, the next-generation left ventricular assist device that came to the company after its acquisition of St. Jude Medical.
“We have identified the potential for a communication error between the patient’s system controller and the [left ventricular assist system] pump which triggers a communication fault advisory alarm on the system controller. We have traced the issue to manufacturing variances from a single supplier that could lead to crystallization formation, which may then disrupt communication between the pump and the system controller.
