BEUDAMED
    FDA Enforcement Class I 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 · Reported July 26, 2017

    Enforcement

    Recall Number
    Z-2702-2017
    Event ID
    77571
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Penumbra Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 26, 2017
    Initiation Date
    June 9, 2017
    Classification Date
    July 20, 2017
    Termination Date
    May 9, 2019
    Address
    1 Penumbra, N/A, Alameda, CA, 94502-7610, United States

    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.

    Code Info

    Lots C00644, C00645, C00646, C00717

    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