Test Integra is recalling the CereLink ICP Monitor, Model #826820/826820P, after reports that the device may display incorrect values for a patient’s intracranial pressure and display out-of-range pressure readings.
If the device is not working properly, the patient may have to undergo additional brain surgeries to replace it, which involves the risks of infection, bleeding, and damage to tissue. Additionally, because the device is used to inform decision-making in critically ill patients (including people with severe traumatic brain injury and stroke) and managing intracranial pressure is key to their care, a malfunctioning device creates a risk of serious injury or death.
Integra reported that there have been 105 global complaints associated with this recall as of July 31, 2022. As of August 24, 2022, the FDA is aware of at least 68 Medical Device Reports (MDRs) associated with this device problem, including reports of patient injury and one patient death.
Call us today if you have an Integra Cerelink ICP Monitor.