Devices

Early Alert on Abiomed Heart Pump Controller Software Problem

FDA has issued an early alert about a potentially high-risk software problem involving certain heart pump controllers manufactured by Abiomed that could temporarily stop circulatory support during treatment. The agency says Abiomed has initiated an urgent medical device correction affecting all Automated Impella Controllers used with left ventricular Impella heart pump devices.

According to FDA, a software error may force the Automated Impella Controller (AIC) to restart under certain clinical conditions, causing the pump to stop functioning for about 35 seconds. During the reboot period, patients may lose hemodynamic support and could experience blood regurgitation through the catheter.

The affected products include several U.S. versions of the Impella Controller and Impella Optical Controller systems.

The issue can occur when a patient using a left ventricular Impella device experiences more than 80 minutes of minimal pulsatility followed by a sudden change in left ventricular pressure while the device is operating above support level P-3. FDA said replacing the controller with another unit would not prevent the problem from recurring because the issue stems from the software itself.

Patients without alternative mechanical circulatory support may face an increased risk of serious injury or death if the controller unexpectedly restarts, the agency said.

Abiomed notified customers May 14 and advised clinicians managing patients who are also receiving veno-arterial extracorporeal membrane oxygenation, or VA-ECMO, to maintain Impella support at P-3 or lower to avoid triggering the software condition.

As of 4/27, Abiomed had reported two serious injuries and one death associated with the problem, according to FDA.

The Automated Impella Controller serves as the primary control interface for Impella catheter systems, which are designed to temporarily support circulation and reduce cardiac workload in critically ill patients.

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