BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-1395-2022 · Reported August 3, 2022

    Enforcement

    Recall Number
    Z-1395-2022
    Event ID
    90457
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 3, 2022
    Initiation Date
    June 22, 2022
    Classification Date
    July 22, 2022
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

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

    Reason

    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.

    Code Info

    UDI-DI- 10381780533778; All serial numbers.

    Distribution

    Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong Kong, Pakistan, Georgia, Saudi Arabia, Israel, South Africa, United Arab Emirates, Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Portugal, Switzerland, Spain, Sweden, Slovakia, and United Kingdom.

    Quantity

    1,210 units