medical Class I Updated 2022-08-03

Integra LifeSciences Corp. recalls CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracra

Recalled Product

CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.


Hazard / Issue

Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by electrical interference from a component of the monitor's circuit board and from the environment.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI- 10381780533778; All serial numbers.
View official government recall

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