The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: CereLink ICP Monitor
- Product Codes: 826820, 826820P
- Serial Numbers: See recall database entry
- Devices Recalled in the U.S.: 388
- Dates distributed: June 1, 2021, to May 31, 2022
- Date Initiated by Firm: June 22, 2022
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.
Reason for Recall
Integra is recalling the CereLink ICP Monitor 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.
Who May Be Affected
- Surgeons including neurosurgeons, neurologists, intensive care unit nurses, and hospitalists who manage patients with stroke, traumatic brain injury, and other conditions, and practitioners who use intracranial pressure devices to monitor patients.
- People who require an intracranial pressure monitor as part of their care.
What to Do
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 their Integra account manager, clinical specialist, or customer service at 800-654-2873 or email mailto:firstname.lastname@example.org.
- Medical device recall database entry
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.