Integra is recalling the CereLink Intracranial Pressure Monitor after reports that the device may display incorrect ICP values and out-of-range pressure readings. FDA has identified this as a class I recall.
As of July 31, Integra has received 105 global complaints associated with this recall.
According to the FDA, the patient death report in the MDR described a malfunctioning CereLink ICP Monitor during use in a critically injured patient, which was mitigated by replacing the ICP sensor.
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