BEUDAMED
    FDA Enforcement Class II Terminated

    Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

    Recall: Z-0528-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0528-2015
    Event ID
    69799
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Concentric Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    November 13, 2013
    Classification Date
    December 8, 2014
    Termination Date
    December 8, 2014
    Address
    301 E Evelyn Ave, N/A, Mountain View, CA, 94041-1530, United States

    Description

    Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

    Reason

    Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.

    Code Info

    Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015

    Distribution

    US Distribution to states of: CA, IN, PA, AL, and NJ.

    Quantity

    10 units