FDA MedWatch - Update - CereLink ICP Monitor by Integra

Class I Recall - Due to Risk of Incorrect Intracranial Pressure Readings

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Update - CereLink ICP Monitor by Integra: Class I Recall - Due to Risk of Incorrect Intracranial Pressure Readings AUDIENCE: Patient, Health Professional, Risk Manager, Neurology, Surgery ISSUE: 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. The patient death reported in the MDR described a malfunctioning CereLink ICP Monitor during use in a critically injured patient, which was mitigated by replacing the ICP sensor. The cause of patient death was determined by Integra to be unrelated to the CereLink ICP Monitor malfunction.  For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The CereLink ICP Monitor is an intracranial pressure monitor. It monitors pressure in brain tissue, which is important to track in patients with head injuries, stroke, surgical and post-operative neurosurgical patients, and patients with other conditions. The device's sensor is implanted in the brain and then connected by a wire to an external patient monitor that displays the pressure readings. These readings are used to monitor and when indicated to guide treatment.  RECOMMENDATIONS: On August 23, 2022, Integra sent a letter to customers that advised them: Stop using the CereLink ICP monitor, Model #826820/826820P, as soon as clinically possible and remove the product from service. Be aware that continued use of a monitor already in place should only be determined by an individualized risk-benefit analysis by the responsible attending clinician. For any new patients, switch to an alternate patient monitoring system. Integra sales representatives will contact customers to provide instructions on how to return the CereLink ICP monitor. Customers with questions or concerns about this recall should contact the company. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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