Early Alert: Heart Pump Controller Issue from Abiomed
A software error has been identified that may cause the Automated Impella Controller to restart when used with left ventricular Impella heart pump devices.
Manufacturers of ventricular assist devices, healthcare facilities utilizing Abiomed heart pump controllers, and software engineering departments within the class III medical device sector.
A controller restart in an active circulatory support environment represents a significant clinical risk. Regulatory teams should interpret this as a potential precursor to a formal recall or Field Safety Corrective Action. This issue suggests a gap in software-hardware interoperability testing or a regression error that could necessitate a mandatory software update or firmware patch across all active units.
QA and Engineering teams should review existing software validation protocols for controller-device interactivity. Clinical teams using these specific configurations should maintain heightened awareness of potential restart cycles while awaiting formal mitigation or software updates. Regulatory departments should prepare for potential field safety notifications or formal recall classification.
A software error may cause the Automated Impella Controller to restart when used in conjunction with left ventricular Impella devices.
Open in openFDA / FDA.gov