FDA Warns About Software Error in J&J’s Abiomed Automated Impella Controllers

The U.S. Food and Drug Administration (FDA) issued an early alert concerning a potentially high-risk issue affecting Johnson & Johnson Abiomed’s Automated Impella Controllers (AIC).

The Automated Impella Controller is the main user control interface for the Impella heart pump catheters. It controls the Impella catheter and monitors it for alarms. Impella therapy aims to reduce the heart’s work and offer support for the circulatory system so the heart can recover.

The company issued affected customers a letter on May 14 that the software error may cause the AIC to restart when used in conjunction with left ventricular Impella devices.

Abiomed identified when a patient is treated with a left ventricular Impella device and experiences an extended period (over 80 minutes) with no residual pulsatility (less than 12 mmHg on the aortic placement signal), the controller may be forced to restart due to an internal software error. This can happen if there’s a sudden change in left ventricular pressure (LVP) while the LVP calculation is active (level of support above P-3). The company noted that disabling the aortic placement signal and LVP display doesn’t prevent the AIC from restarting.

During the restart, the screen will turn black without further alert and the pump will stop for about 35 seconds based on preliminary data. During this time, the patient is not supported by the Impella system and regurgitation via the cannula can occur. After the AIC restarts, the pump will automatically resume at the previous P-level.

The company advised that patients without alternate mechanical support in place could be at heightened risk for serious injury or death because of the resulting lack of hemodynamic support in the event of system reboot. Product isn’t being removed and hospital inventory can still be used—Abiomed said it’s working on a software update to address the issue.

As of April 27, Abiomed reported two serious injuries and one death related to the issue.

Earlier this year, the company updated the use instructions for its Impella RP with SmartAssist and Impella RP Flex heart pumps, following the issue of a Class I recall.