Abiomed recalled 71 Automated Impella Controllers on August 20, 2025. The devices may fail to perform correctly, leading to pump stoppage. Healthcare providers and patients must stop using these devices immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abiomed, Inc. or your healthcare provider for instructions. Notification method: Letter
The recall affects the following product codes: 0042-0000-US, 0042-0000-US-L, 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, and 0042-0000-UK-L. The devices were distributed in the US and internationally, including Canada, Germany, Great Britain, Italy, Netherlands, and Norway.
The Automated Impella Controllers may experience decreased performance or complete pump failure. This malfunction can trigger alarms indicating an Impella Failure or Impella Stopped Controller Failure.
No specific incidents or injuries have been reported related to this recall. However, the potential for device malfunction poses serious health risks.
Patients and healthcare providers should cease use of the affected devices immediately. Contact Abiomed, Inc. or your healthcare provider for further instructions and follow the manufacturer’s recall guidance.
For further information, contact Abiomed at [phone number not provided]. Visit the FDA website for details on the recall.
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