FDA Warns on Abiomed Impella Controller After Reported Death

The U.S. Food and Drug Administration has issued a safety warning for Abiomed’s Automated Impella Controller after receiving a report of one patient death associated with the device. No serious injuries have been documented, the agency said, citing data collected up to Aug. 12. The regulator urged clinicians and facilities using the Impella system to review the notice and follow any updated instructions for use. Abiomed, a subsidiary of Johnson & Johnson, has not publicly disclosed additional details on potential corrective actions.