BEUDAMED
    FDA Enforcement Class II Ongoing

    Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.

    Recall: Z-2173-2026 · Reported May 20, 2026

    Enforcement

    Recall Number
    Z-2173-2026
    Event ID
    98752
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp. (NeuroSciences)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2026
    Initiation Date
    April 10, 2026
    Classification Date
    May 13, 2026
    Address
    1100 Campus Rd, Princeton, NJ, 08540-6650, United States

    Description

    Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.

    Reason

    Out-of-specification endotoxin result that did not meet the acceptance criteria.

    Code Info

    Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.

    Distribution

    US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR), California (CA), Connecticut (CT), Florida (FL), Kentucky (KY), Louisiana (LA), Michigan (MI), Minnesota (MN), Missouri (MO), North Carolina (NC), North Dakota (ND), Oklahoma (OK), Oregon (OR), Texas (TX), Washington (WA).

    Quantity

    40 packs (200 units)