FDA Media Alert Detail

FDA Safety Alert

Early Alert: Heart Pump Controller Purge Cassette Issue from Abiomed

  • U.S. Food and Drug Administration
  • August 26, 2026
  • ID: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-heart-pump-controller-purge-cassette-issue-abiomed

FDA MedWatch Safety Alert

Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.

Content syndicated from the official FDA MedWatch Safety Alerts and Adverse Event Reporting Program.