Integra LifeSciences is recalling 4,941 CereLink ICP Extension Cables (Model No. 826845) because they can provide "out of range" or incorrect pressure readings during patient monitoring. This recall expands upon a previous 2022 action to include all extension cables due to a design defect that requires a hardware change. These cables are used with the Codman CereLink Intracranial Pressure (ICP) Monitor to track pressure inside a patient's skull, and the malfunction can lead to incorrect medical treatment or clinical decisions.
The extension cables can provide inaccurate intracranial pressure readings or fail to display data entirely. If medical staff rely on these incorrect readings, it could lead to delayed or inappropriate surgical intervention for critical brain conditions, potentially causing permanent neurological damage or death.
Design change and corrective action
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.
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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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