Abiomed, Inc. is recalling approximately 11,031 Automated Impella Controller (AIC) units, which are used to manage left heart support blood pumps. The recall was initiated because the controller may fail to detect an Impella pump even after it has been properly connected to the system. This defect affects various models of the controller distributed worldwide between June and July 2025. Because this is a life-sustaining medical device, consumers and medical staff should contact their healthcare provider or Abiomed immediately for technical support and guidance.
If the controller fails to recognize the heart pump, it may result in the pump failing to start or stopping unexpectedly. This failure to provide critical circulatory support can lead to life-threatening complications for patients who rely on the device for heart function support.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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