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Early Alert: Automated Impella Controller Purge Retainer Fixation Issue from Abiomed

September 23, 2025

FDA is announcing an Early Alert for Abiomed’s Automated Impella Controller due to Purge Pressure Issues

Original Source: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-automated-impella-controller-purge-retainer-fixation-issue-abiomed

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