BEUDAMED
    FDA Enforcement Class II Ongoing

    The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.

    Recall: Z-0021-2025 · Reported October 16, 2024

    Enforcement

    Recall Number
    Z-0021-2025
    Event ID
    95314
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Neurovascular
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2024
    Initiation Date
    August 30, 2024
    Classification Date
    October 7, 2024
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515, United States

    Description

    The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.

    Reason

    Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.

    Code Info

    Model/Catalog Number: 90338 UDI Codes: (01)07613327313956(17)251125(10)0000590444 (01)07613327313956(17)260101(10)0000603275 Lot Numbers: 0000590444 0000603275

    Distribution

    U.S. Nationwide distribution in the states of CA and VA.

    Quantity

    6