FDA: Heart Pump Controller Purge Cassette Issue from Abiomed

Published: 08/26/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Critical Access Hospitals,
  • Hospitals

The FDA is aware that Abiomed has issued a letter to affected customers recommending all Automated Impella Controllers be removed from where they are used or sold.

  • The Automated Impella Controller is the primary user control interface for the Impella Catheter. It controls the Impella Catheter performance, monitors the catheter for alarms, and provides catheter position information regarding the location of the catheter across the aortic valve.

Abiomed is removing Automated Impella Con…

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