FDA: Class I recall of Integra’s CereLink ICP Monitor

Editor's Note

The Food and Drug Administration (FDA) on August 31 identified the recall by Integra of its CereLink ICP Monitor as Class I, the most serious.

The recall was initiated because the device may display incorrect values for a patient’s intracranial pressure (ICP) and display out-of-range pressure readings. If the device is not working properly, the patient may have to undergo neurosurgery to replace it.

There have been 105 complaints worldwide as of July 31, and as of August 24, there have been at least 68 medical device reports to the FDA associated with this device issue.

Distribution dates were June 1, 2021, to May 31, 2022.