Abiomed has decided to initiate a voluntary medical device recall (removal) for Automated Impella Controllers (AICs) in the field related to a design change that improves the AIC purge retainer fixture and addresses potential purge retainer failures. Failures impacting purge pressure and detection of the purge disc may lead to errors, alarms, and potential interruptions in hemodynamic support when the AIC may need to be replaced.
RecallTracker