FDA Media Alert Detail

FDA Safety Alert

Early Alert: Heart Pump Controller Issue from Abiomed

  • U.S. Food and Drug Administration
  • September 23, 2026
  • ID: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-heart-pump-controller-issue-abiomed

FDA MedWatch Safety Alert

Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records.
Content syndicated from the official FDA MedWatch Safety Alerts and Adverse Event Reporting Program.
View Official Announcement on FDA.gov

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