BEUDAMED
    FDA Recall Terminated

    Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

    Recall: Z-0001-2010 · Initiated September 22, 2009

    Recall

    Recall Number
    Z-0001-2010
    Event Number
    53426
    Firm
    Penumbra Inc.
    FEI Number
    3005168196
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 22, 2009
    Posted
    October 5, 2009
    Terminated
    November 24, 2010
    Address
    1351 Harbor Bay Pkwy, Alameda, CA, 94502-6541

    Description

    Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

    Reason

    Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient.

    Action

    The firm issued an Urgent Voluntary Field Removal Notice letter on 09/22/2009 to its consignees, asking them to inspect their stocks; remove affected product and place in quarantine for return to Penumbra Inc.; and complete and return the attached product identification / return form.

    Distribution

    Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.

    Quantity

    2246 units