Abiomed, Inc. has recalled 10,153 units of the Automated Impella Controller (AIC), a device used to provide left heart support for blood pumps. The recall is due to potential cybersecurity vulnerabilities within the controller's operating system. These vulnerabilities could theoretically allow an unauthorized user to gain access to the device's system settings or operations.
Unauthorized access to the controller's operating system could allow a malicious user to interfere with device functions or settings, which could lead to a loss of heart support for the patient. While no injuries have been reported specifically due to this issue, the cybersecurity risk is considered critical for life-support equipment.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
Used for left heart support blood pump.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.