BEUDAMED
    FDA Recall Terminated

    Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) 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-2702-2017 · Initiated June 9, 2017

    Recall

    Recall Number
    Z-2702-2017
    Event Number
    77571
    Firm
    Penumbra Inc.
    FEI Number
    3005168196
    Product Code
    NRY
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    June 9, 2017
    Posted
    June 22, 2017
    Terminated
    May 9, 2019
    Address
    1 Penumbra, Alameda, CA, 94502-7610

    Description

    Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) 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

    Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.

    Action

    Penumbra sent an Urgent Voluntary Field Removal Notice dated June 9, 2017. Customers were instructed to inspect current inventory and remove any affected units for return. Customers were also instructed to return the response form. Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death. Penumbra personnel will contact customers directly to arrange return of affected units and replacement of returned product at no charge to them. Customers with question should call 1-510-748-3288.

    Distribution

    Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV

    Quantity

    155 units