FDA Provides Update on Integra’s Recall of CereLink ICP Monitors
The FDA has issued an update on Integra’s June 22 recall of 388 of its CereLink ICP Monitors, deeming it a Class 1 because of the risk of serious injury and death.
The CereLink ICP monitors pressure in brain tissue in patients with head injuries, stroke, surgical and postoperative neurosurgical patients, and other conditions.
The company recalled the device after receiving reports that it may display incorrect values for a patient’s intracranial pressure and display out-of-range pressure readings.
The device’s sensor is implanted in the brain and connected by a wire to an external patient monitor that displays the pressure readings, so if the device is not working properly, additional surgeries to replace the device might be needed, putting the patient at risk.
The 388 affected devices were distributed from June 1, 2021, to May 31, 2022. There have been 105 complaints globally, plus at least 68 Medical Device Reports, including reports of patient injury and one patient death so far, the FDA said.
However, the cause of patient death was determined by Integra to be unrelated to the CereLink ICP Monitor malfunction.