Medical devices
Abiomed advises removal of certain automated Impella controllers
Affected controllers should be removed from use or sale for updates, though hospital inventory may be used while awaiting service to maintain continuity of care.
Abiomed advised customers to remove certain Automated Impella Controllers (AICs) from where they are used or sold after a retrospective review of servicing records identified units needing hardware, firmware and/or software updates, the FDA said. The FDA identified the recall as the most serious type. Hospital inventory may continue to be used while awaiting service to ensure continuity of care.
The potential issues include failure to recognize a purge cassette during setup or change, a sticking or unreliable button that could affect menu selection and confirmation and possibly cause loss of console control, start-up instability, and other software defects. Without updates, patients could face delayed therapy, inadequate or lost hemodynamic results, and other serious issues. Abiomed sent affected customers a letter on September 18, 2026. As of September 8, 2026, the company had reported no serious injuries or deaths associated with the issue.
