Health & Personal Care
HIGH
FDA DEVICE
Abiomed Impella Controller AIC Recall 2025 Affects 71 Units Across 6 Regions
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
Abiomed
Specific Automated