CereLink (intracranial pressure gauges)

2022: Recall of CereLink monitors due to marriage

On August 18, 2022, Integra LifeSciences announced the start of a voluntary global recall of all CereLink intracranial pressure monitors after receiving customer reports that device readings were out of range.

According to the press release, Integra believes that the fault is caused mainly by electrical interference from the outside and/or interference from the component on the printed circuit board of the monitor. The company said readings outside the range took place at a "low frequency" and at a limited number of facilities.

CereLink monitors are being recalled

Despite the low frequency of problems and the number of sites where they were recorded, the company said that its decision to remove all CereLink monitors from service was dictated by an "excess of caution."

Integra is investigating to fix the problem seen. She plans to resume deliveries of CereLink monitors as soon as all such problems are resolved.

Voluntary action is not expected to have a material negative impact on its business, financial condition or results of operations, Integra said. However, the company expects a refund provision of about $9 million in the third quarter of 2022 and has adjusted its forecasts for the third quarter and all of 2022 accordingly.

In June 2022, the company released a letter to customers informing them of the issue and troubleshooting practices while it investigated the root cause, according to an FDA record. The review included 1,210 devices around the world. In July 2022, the FDA classified it as a Class I recall - the highest risk category.^[1]

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