BEUDAMED
    FDA Enforcement Class II Ongoing

    CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

    Recall: Z-2329-2026 · Reported June 17, 2026

    Enforcement

    Recall Number
    Z-2329-2026
    Event ID
    98922
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    INSPIREMD Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2026
    Initiation Date
    May 1, 2026
    Classification Date
    June 5, 2026
    Address
    6303 Waterford District Dr Ste 215, N/A, Miami, FL, 33126-6004, United States

    Description

    CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

    Reason

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

    Code Info

    UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026

    Distribution

    US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV.

    Quantity

    114 units