BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1395-2022 · Initiated June 22, 2022

    Recall

    Recall Number
    Z-1395-2022
    Event Number
    90457
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    GWM
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 22, 2022
    Posted
    July 22, 2022
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650

    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.

    Action

    A recall notification titled 1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION, dated June 22, 2022, was sent by mail. This communicated troubleshooting techniques if an out-of-range reading is encountered when utilizing the Codman CereLink System, while Integra finalized a root cause investigation. A second notification, dated August 23, 2022, for this recall states that Integra is now conducting a removal of Codman CereLink ICP Monitors. Customers are asked to discontinue use of affected devices as soon as possible and remove the devices from service. If an affected device is being used on a patient, continued use should only be determined by an individual risk-benefit analysis by the responsible attending clinician. If the recalled device continues to be used on a patient, the patient needs to be carefully monitored and ensure cable management. If a progressive decline in ICP readings is observed, use another monitoring system for continued patient case as soon as possible. Once patient care is complete, discontinue use of the monitor and remove it from service. As CereLink ICP Monitors are removed from use, a sales representative will facilitate the return of the affected monitor. Complete the Acknowledgement Form and return it to your Account Manager or email it to [email protected] or Fax the form to 1-609-750-4220. Keep a copy of the recall notification for your records. Any questions, contact your Integra Account Manager, Clinical Specialist, or Technical Support at [email protected] or by phone at 888-772-7378.

    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