Automated Impella® Controllers (AIC)

Issue

Abiomed has decided to initiate a voluntary medical device recall (removal) for design changes that were previously implemented through the Abiomed field service process. Abiomed performed a retrospective review of Field Change Notices (FCN) and determined that certain AIC consoles in the field did not receive the updates introduced by FCN 113.Failure to implement the applicable FCN 113 updates may result in the screen freezing during the Purge Cassette Change Wizard and the display of a false controller error.These defects could delay the initiation of support during device set-up and, in high-risk patient populations, may lead to temporary inadequate hemodynamic support or a temporary loss of hemodynamic support. Hospital inventory may continue to be used to ensure continuity of care. Not all units are affected by this issue.