Integra LifeSciences Recalls CereLink Intracranial Pressure Monitors, Revises Guidance

Integra LifeSciences Holdings Corporation IART initiated an immediate voluntary removal of all CereLink intracranial pressure monitors after customer reports about monitors whose pressure readings were out of range.
The company believes that out-of-range readings are principally caused by electrical interference from the external environment and/or interference from a component on the monitor's circuit board.
These out-of-range readings have occurred at a low incidence rate and at a limited number of sites; however, the company has decided to remove all CereLink monitors out of caution.
Related: Piper Sandler Cuts Price Target For Integra Lifesciences As It Divests Wound Care Portfolio.
The company is continuing its investigation and plans to resume shipment of the CereLink monitors as soon as any such issues have been resolved.
Integra estimates a returns provision of approximately $9 million in Q3 of 2022 and has adjusted its third quarter and full year 2022 guidance accordingly.
It forecasts Q3 adjusted EPS of $0.69-$0.73 (consensus of $0.84) and sales of $374-$382 million ($398.66 million), down from previous guidance of $0.78-$0.82 and $383-$391 million.
For FY22, Integra has revised its sales guidance to $1.55-1.57 billion (consensus of $1.59 billion) from $1.56-$1.58 billion and adjusted EPS of $3.12-$3.20 (consensus of $3.31) versus the previous outlook of $3.21-$3.29.
Price Action: IART shares are down 1.22% at $51.22 during the premarket session on the last check Wednesday.