Abiomed is recalling 4,463 Automated Impella Controller (AIC) units with software versions V8.4 and V8.4.1. This recall was initiated because the controller software may fail to recognize the Impella heart pump, which is used for cardiovascular ventricular support. A software update (Version 8.5) has been released to fix this specific issue and ensure the pump is correctly identified and managed by the controller. These devices were distributed across the United States starting in March 2021.
If the AIC software does not recognize the connected pump, it may fail to provide critical cardiovascular support to the patient, potentially leading to a delay in treatment or a loss of support during a procedure.
You have 2 options:
Software update to version 8.5
Manufacturer consultation
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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