FDA DeviceClass INotable
FDA Recall: Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the foll
Description
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Hazard
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Remedy
10,297 units
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