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Early Alert: Heart Pump Controller Issue from Abiomed
The FDA is aware that Abiomed has issued an Urgent Medical Device Recall (Correction) notice to affected customers recommending updated use instructions for all Automated Impella Controllers (AIC).
Abiomed has identified that when a patient is treated with a left ventricular Impella device and experiences an extended period (>80 minutes) with no residual pulsatility (<12 mmHg on the aortic placement signal), the Automated Impella Controller (AIC) may be forced to restart because of an internal software error. This can occur if there is a sudden change in left ventricular (LV) pressure while the left ventricular pressure (LVP) calculation is active (level of support above P-3). Disabling the aortic placement signal and the LVP display does not prevent the AIC from restarting.
During the restart, the AIC screen will turn black without further alert and the pump will stop for a duration of approximately 35 seconds based on preliminary data, during which the patient is unsupported by the Impella system and regurgitation via the cannula may occur. After the AIC restarts, the pump will automatically resume at the previous P-level. Replacement of the AIC with another AIC would not resolve the potential for an AIC restart.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Abiomed at OneMD-Field-Actions@its.jnj.com.
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