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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
Mazda North American Operations is recalling 2024 CX-90 and 2025 CX-70 SUVs sold through Mazda dealers. The PCM and ECM software can illuminate malfunction indicator lights and cause a loss of drive power, increasing crash risk. Owner notification letters were mailed December 19, 2024, and Mazda will reprogram the PCM and ECM at no charge.
Mazda North American Operations recalls 2025 Mazda CX-70 plug-in hybrids as software issues in the inverter may cause the malfunction indicator lights to illuminate and a loss of drive power in EV mode. Dealers will update inverter software at no cost. Letters were mailed December 19, 2024.
Mazda North American Operations recalls certain 2024-2025 CX-90 and 2025 CX-70 vehicles with a Dash ESU due to startup function failures. Software reprogramming will remedy the issue at no charge. Owner notices were mailed December 18, 2024. Contact Mazda at 1-800-222-5500 Option 6. NHTSA ID 24V814000.
Subaru recalls 2025 Forester vehicles due to potentially loose child seat anchor bolts. Dealers will inspect and tighten bolts at no charge. Owner letters are expected August 15, 2025. Contact Subaru at 1-844-373-6614. Recall number WRC-25.
Nissan recalls 2025 Pathfinder, Murano and INFINITI QX60 for front brake caliper weakness that could fail. Dealers will inspect and replace calipers as needed, free of charge. Letters sent May 9, 2025. Contact Nissan or INFINITI for remedies.
Mazda North American Operations is recalling 2025 CX-50 Hybrid and CX-50 SUVs sold through Mazda dealers. Incorrectly configured restraint-control software may cause the air bag to deploy improperly. Owner notification letters are expected to be mailed August 17, 2025.
Nissan North America is recalling certain 2025 Nissan Kicks vehicles sold through Nissan dealers nationwide. The certification label may print incorrect GVWR and GAWR values, risking overload. Some SR trims with a 19-inch wheel package may display an incorrect wheel size on the label, and owners should contact their Nissan dealer to arrange replacement labels.
BMW recalls 2025-2026 X1 and X2 models plus MINI Cooper and Countryman variants for front seat belt retractors with damaged torsion bars. The defect may fail to restrain occupants in a crash. Dealers will replace both front retractors at no cost. Owner letters begin November 7, 2025. VIN lookup will be available on NHTSA.gov the same day.