Abiomed issues recall of Automated Impella Controllers over purge cassette detection issue

Abiomed has announced a recall of its Automated Impella Controllers after identifying failures in the purge cassette recognition system, which could lead to prolonged delays in mechanical circulatory support.

The FDA has classified the recall as the most serious type, warning that continued use of the devices may result in serious injury or death.

The company advised customers to remove all affected controllers from clinical use or sale. Hospitals may retain inventory but should rely on backup controllers until replacements are provided.

In the event of an alarm triggered by the purge flag component, users should first reinsert the purge disc; if the alarm persists, they must switch to a backup controller. Abiomed sent these instructions to customers on August 12.