BEUDAMED
    FDA Recall Terminated

    Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.

    Recall: Z-2049-2009 · Initiated July 2, 2009

    Recall

    Recall Number
    Z-2049-2009
    Event Number
    52963
    Firm
    Penumbra Inc.
    FEI Number
    3005168196
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 2, 2009
    Posted
    September 8, 2009
    Terminated
    January 5, 2011
    Address
    1351 Harbor Bay Pkwy, Alameda, CA, 94502-6541

    Description

    Penumbra Neuron 5F Select Catheter, Neuro Deliver/Intracranial Access System Catheter, manufactured by Penumbra, Inc., Alameda, CA. Intended for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.

    Reason

    Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage.

    Action

    Penumbra, Inc. initiated Recall activities on May 29, 2009. The Firm notified consignees via telephone and email of the problem and asked them to return the product to Penumbra. For further information, contact Penumbra, Inc. at 1-510-748-3223.

    Distribution

    Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada.

    Quantity

    9 units