The company on Aug. 18, 2022, initiated the product removal of all CereLink intracranial pressure monitors as a result of customer reports about monitors whose pressure readings were out of range.
According to a news release, Integra believes that the out-of-range readings have been principally caused by electrical interference from the external environment and/or interference from a component on the circuit board of the monitor. The company said the out-of-range readings have occurred at “a low incidence rate” and at a limited number of sites.
Despite the low rates and site numbers, the company said its decision to remove all CereLink monitors from the field comes “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 any such issues have been resolved.
According to Integra, the voluntary action is not expected to have a material adverse effect on its business, financial condition or the results of operations. Still, the company estimates a returns provision of approximately $9 million in the third quarter of 2022 and has adjusted its third quarter and full year 2022 guidance accordingly.
Its revenue estimates for the full year now fall between $1.548 billion and $1.566 billion, with adjusted EPS guidance set for between $3.12 and $3.20. The previous EPS projection was for between $3.21 and $3.29, which the company set on the back of its second-quarter results released last month.
