🇨🇦 Impella Controller

Hazard/Reason: 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.  

This page links to official sources. Verify model/lot/batch details in the official notice.