Abiomed’s automated Impella Controller recall covers 71 units distributed across the US and international markets. The devices may have a Pump Driver Circuit Assembly that does not meet current specifications. This can reduce pump performance or trigger a pump stop with alarms. Clinicians and patients should follow manufacturer instructions and contact Abiomed or healthcare providers for guidance.
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
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Impella Controller is used with a heart assist pump for cardiac support. The AIC manages pump function.
A Pump Driver Circuit Assembly that does not meet specifications can cause the pump to underperform or stop, triggering alarms.
This recall is not part of a broader industry pattern.
High risk to patients requiring precise pump function during cardiac support; impact includes potential treatment delay and hospital readjustments.
FDA recall page Z-2568-2025 and Abiomed recall communications.
Remedy processing timelines vary; expect weeks to months for refunds or replacements.
Keep recall notice, device identifiers, batch numbers, and all correspondence.
Brand: Abiomed. Product: Automated Impella Controller (AIC). Models/Codes: 0042-0000-US, 0042-0000-US-L, 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, 0042-0000-UK-L. Sold to US states: AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH, PA, TX. International distribution: Canada, Germany, Great Britain, Italy, Netherlands, Norway. Recall date: 2025-08-20. Status: ACTIVE. Hazard level: HIGH. Quantity: 71 units.
No specific incident counts are provided in the recall data. The FDA notice indicates a Class I risk.
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