Integra Recalls CereLink ICP Monitor

The U.S. Food and Drug Administration (FDA) has identified Integra LifeSciences’ June 22 recall of its Cerelink ICP (intracranial pressure) monitor as Class I.
 
Integra recalled the Cerelink ICP monitor following reports it may display incorrect values for intracranial pressure and show out-of-range pressure readings.
 
The device monitors pressure in brain tissue, important to track in patients with head injuries, stroke, surgical and post-operative neurosurgical patients, and patients with other conditions. The sensor is implanted in the brain and connected to a wire to an external monitor that displays pressure readings, which are used to monitor and when indicated, to guide treatment.
 
If the device isn’t working correctly, additional brain surgeries may be needed to replace it—which can risk infection, bleeding, and tissue damage. Because the device informs decision-making in people with severe traumatic brain injury and stroke and managing ICP is key to care, a malfunctioning device creates risk of serious injury or death.
 
Integra reported there have been 105 complaints globally as of July 31. As of August 24, FDA is aware of at least 68 Medical Device Reports associated with the problem, including one injury and one death.
 
The death, according to FDA, described a malfunctioning monitor used in a critically injured patient that was replaced with a working ICP sensor. Integra determined the cause of death was unrelated to the Cerelink ICP monitor malfunction, however.
 
Integra advised customers to Stop using the CereLink ICP monitor, Model #826820/826820P, as soon as clinically possible and remove the product from service.
 
Integra has recalled 388 device in the U.S. distributed between June 1, 2021 and May 31, 2022.