Abiomed, Inc. is recalling seven Automated Impella Controllers (AIC) with software versions V8.4 and V8.4.1. This recall includes models 0042-000-US and 0042-040-US distributed in five U.S. states. The recall was initiated because a software issue can prevent the controller from detecting that the heart pump is connected, which could interfere with critical heart support operations. Consumers should contact their healthcare provider or the manufacturer to discuss the issue and ensure their devices are updated or functioning correctly.
A software bug prevents the controller from recognizing a connected heart pump. If the pump is not detected, it may fail to provide necessary circulatory support, potentially leading to serious health complications for patients relying on the device for heart function.
Manufacturer assistance and healthcare coordination
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.
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Sources: FDA iRES · Raw API Response
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