Impella Controller

Product Impella Controller Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information. Audience Healthcare

Abiomed, Inc. has issued a voluntary device recall (correction) to notify customers of a potential software error in the Automated Impella Controller ("AIC") which may be forced to restart when used in conjunction with left ventricular Impella devices. This potential software error, in a specific clinical circumstance, could contribute to serious injury or death in certain patient populations. Product is not being removed, and hospital inventory can continue to be used.

RA-82061