HeartMate II® LVAS - System Controller

Companies: Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, California, United States, 94588.

Abbott is initiating a voluntary medical device recall for the HeartMate II® and HeartMate 3™ System Controllers. This recall does not involve device removal from where they are used or sold.

Abbott has observed an increase in customer complaints about the controller Backup Battery Fault Alarm. This alarm is indicated by a flashing yellow wrench on the user interface of the System Controllers. When the controller is connected to an external power source (e.g. 14V batteries or AC power via the Mobile Power Unit), this is an advisory alarm and does not indicate a critical system failure or impact pump functionality.

To reduce future instances of the Backup Battery Fault Alarm, Abbott is advising that when performing backup battery installation or replacement, clinicians should minimize excessive handling, movement, stress and pulling at the interface between the ribbon cable and controller. An example of excessive handling would be using the ribbon cable to hold the weight of the controller.

Please remind patients and caregivers to follow the patient handbook: if System Controller Backup Battery Fault Alarm is active, patients should first ensure that no other alarms are active, and then they should call their hospital contact as soon as possible for diagnosis and instructions. Patients and caregivers should not immediately attempt to exchange the system controller without clinical guidance.