Abiomed, Inc. is recalling 71 units of its Automated Impella Controller (AIC) because specific pump driver circuit assemblies do not meet current manufacturing specifications. This defect can cause the heart assist pump to perform poorly or stop entirely, which triggers "Impella Failure" or "Impella Stopped" alarms on the controller. The affected units were distributed to 17 US states and internationally between August and September 2025.
If the controller fails, the heart assist pump may stop providing critical support to the patient's heart. This could lead to serious medical complications or life-threatening situations for patients who depend on the device for circulatory support.
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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