FDA alerts hospitals to purge cassette fault in Abiomed Impella controllers

The FDA issued an Early Alert after identifying a problem with the purge cassette recognition in Abiomed’s Automated Impella Controllers, which could cause prolonged delays in mechanical circulatory support.

Abiomed sent a letter to affected customers on August 12, advising that all impacted controllers be removed from use or sale. The guidance instructs staff to first reinsert the purge disc to clear any alarm, and if the alarm persists, to switch to a backup controller.

Hospitals may continue to use existing inventory while waiting for replacements, provided they follow the troubleshooting steps. The letter also emphasizes proper cleaning of the controller housing with mild detergent and recommends annual preventive maintenance to avoid damage to plastic components.

The FDA will keep the public updated as more information becomes available.