The U.S. Food and Drug Administration (FDA) has issued an early alert regarding Abiomed's Automated Impella Controller (AIC), following an Urgent Medical Device Recall (Correction) notice from the manufacturer.
Abiomed identified a software error that can force the AIC to restart if a patient with a left ventricular Impella device experiences an extended period of over 80 minutes with no residual pulsatility, particularly with sudden changes in left ventricular pressure while the pressure calculation is active.
During a restart, the AIC screen turns black, and the pump stops for approximately 35 seconds, leaving the patient unsupported and potentially causing regurgitation. The pump automatically resumes at its previous support level after restarting, but replacing the AIC does not resolve the underlying software issue.