The U.S. Food and Drug Administration (FDA) has issued an "Early Alert" regarding Abiomed's recall of its Automated Impella Controllers (AICs) due to critical purge cassette recognition issues. This action follows reports of 37 serious injuries and three deaths associated with the device malfunction.
Abiomed is removing all affected AICs from use and sale. The issue stems from failures of the purge flag component within the purge pressure sensor assembly, which prevents the controller from properly recognizing the purge disc. This can lead to delays in starting procedures or interruptions during active mechanical circulatory support.
If a failure occurs before support begins, it may cause a prolonged period without necessary circulatory support, especially in hemodynamically unstable patients. During active support, while mechanical support continues, purge delivery stops, necessitating an urgent AIC exchange. CDRH said, "CDRH is issuing this 'Early Alert' to notify the public of a potentially high-risk device issue." The FDA will continue to monitor the situation and provide updates.