Automated Impella Controller (AIC)

Companies: Abiomed Inc., 22 Cherry Hill Drive, Danvers, Massachusetts, United States, 01923.

Abiomed has initiated a voluntary medical device recall (removal) after identification of an increase in complaints related to purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. The cause of the purge flag failures is a combination of dextrose buildup from a purge cassette leak and material embrittlement from usage, aging, or exposure to cleaning chemicals. This issue may occur from usage and is not a manufacturing defect. The purge flag component is present in all manufactured Automated Impella Controller (AIC) in Canada. However, product may continue to be used to ensure continuity of care and a prioritized risk-based strategy for component replacement will be implemented.

The purge flag is the component that engages with the purge disc and allows the AIC to recognize the purge disc. These AIC purge flag component failures may result most frequently in user inconvenience due to troubleshooting, attempted purge cassette exchange and AIC exchange. If the failure occurs before initiation of support, exposure may result in a delay to procedure, which is expected to remain clinically manageable in most cases. In the case of an urgent need for mechanical circulatory support or if the failure occurs during active Impella support, exposure may result in a temporary period of inadequate hemodynamic support during controller transition.