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Integra designed its CereLink system for intracranial pressure (ICP) monitoring. Last week, the company announced an immediate, voluntary global product removal of the systems.

An FDA notice classified the U.S. recall, initiated by Integra on June 22, 2022, as the most serious kind yesterday. Integra recalled a total of 388 devices (product codes 826820 and 826820P) in the U.S. The company distributed affected devices between June 1, 2021, and May 31, 2022.

Integra reported 105 global complaints associated with the recall as of July 31, 2022. As of Aug. 24, the FDA received at least 68 reports associated with the issue. Reports include one patient injury and one patient death. The report of death described a malfunctioning CereLink monitor during use in a critically injured patient. Replacing the ICP sensor mitigated the issue and the cause of death was determined to be unrelated to the CereLink malfunction.

The recall comes as a result of customer reports about monitors whose pressure readings were out of range. Integra believes electrical interference from the external environment and/or interference from a component on the circuit board of the monitor caused the out-of-range readings. The company said the out-of-range readings occurred at “a low incidence rate” and at a limited number of sites. It initiated the recall “out of an abundance of caution.”

Integra is investigating the matter to remedy the observed issue. It plans to resume shipment of the CereLink monitors as soon as it resolves any such issues.

CereLink ICP monitors pressure in brain tissue to track patients with head injuries, stroke and more. A sensor is implanted in the brain and connected by wire to an external monitor that displays pressure readings. The readings help to guide treatment.

If the device isn’t working properly, a patient may have to undergo additional brain surgeries. That involves risks of infection, bleeding, and damage to tissue, according to the FDA. Because the device use covers critically ill patients, malfunction creates the risk of serious injury or death.

Filed Under: Featured, Food & Drug Administration (FDA), Neurological, News Well, Patient Monitoring, Recalls, Regulatory/Compliance Tagged With: FDA, Integra LifeSciences

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