BEUDAMED
    FDA Recall Terminated

    Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.

    Recall: Z-0428-2011 · Initiated October 25, 2010

    Recall

    Recall Number
    Z-0428-2011
    Event Number
    57166
    Firm
    Penumbra Inc.
    FEI Number
    3005168196
    Product Code
    NRY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 25, 2010
    Posted
    November 24, 2010
    Terminated
    June 1, 2011
    Address
    1351 Harbor Bay Pkwy, Alameda, CA, 94502-6541

    Description

    Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.

    Reason

    Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.

    Action

    Penumbra issued an Urgent Voluntary Field Removal letter dated October 28, 2010 to consignees, identifying the affected device and actions to be taken by consignees. Customers were instructed to inspect their inventory for the affected product and quarantine it, pending return to Penumbra. Penumbra employees will contact customers to arrange return and replacement of affected units. Customers were also requested to complete and return a product identification form and return form to Penumbra within 5 business days. Customers can contact Penumbra at 1 510 748-3223 concerning this action.

    Distribution

    Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA, and TX, 1 in Canada and 21 in the EU countries of France, Germany, Hungary, Italy, Norway, Slovenia, Spain, and the United Kingdom.

    Quantity

    61