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# Integra CereLink Monitor Recall is Class 1
- URL: https://www.fdaweb.com/integra-cerelink-monitor-recall-is-class-1/
- Published: 2022-09-01T12:00:00.000Z
- Updated: 2026-09-14T17:58:07.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152643

FDA says the 6/22 Integra recall of 388 CereLink ICP monitors is Class 1\. An agency [notice](https://www.fda.gov/medical-devices/integra-recalls-cerelink-icp-monitor-risk-incorrect-intracranial-pressure-readings?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the affected intracranial pressure monitors were distributed in the U.S. between 6/1/21 and 5/31/22\. Integra recalled the units after reports that they may display incorrect values for a patient’s intracranial pressure and display out-of-range pressure readings, the notice says.

The company told FDA there had been 105 complaints globally associated with the recall as of 7/31\. The agency says that as of 8/24 it is aware of at least 68 medical device reports associated with the problem, including reports of patient injury and one patient death. FDA says the company determined that the death was not related to the monitor malfunction.