BEUDAMED
    FDA Recall Open, Classified

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

    Recall: Z-2328-2026 · Initiated May 1, 2026

    Recall

    Recall Number
    Z-2328-2026
    Event Number
    98922
    Firm
    INSPIREMD Inc
    FEI Number
    3032814119
    Product Code
    NIM
    Status
    Open, Classified
    Root Cause
    Component design/selection
    Initiated
    May 1, 2026
    Posted
    June 5, 2026
    Address
    6303 Waterford District Dr, Ste 215, Miami, FL, 33126-6004

    Description

    Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

    Reason

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

    Action

    On May 1, 2026, InspireMD, Inc. issued a Urgent Medical Device Recall notification to affected consignees. InspireMD asked consignees to take the following actions: 1. Cease further use of all affected CGuard Prime Carotid Stent Systems identified by the model numbers listed in the letter. 2. Quarantine and segregate all affected units currently in your inventory. Place affected product in a clearly labeled quarantine area to prevent inadvertent use. 3. This notice needs to be passed on to all those who need to be aware within your organization or facilities where the affected devices have been transferred. 4. Please retain a copy of this letter, and keep a copy of the Acknowledgement Form. 5. Complete the attached Acknowledgement Form and return it by email to [email protected] within 2 business days. 6. InspireMD will contact each affected customer to facilitate the return and disposition process.

    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

    291 units