BEUDAMED
    FDA Recall Terminated

    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

    Recall: Z-2471-2012 · Initiated September 23, 2011

    Recall

    Recall Number
    Z-2471-2012
    Event Number
    63188
    Firm
    Micro Therapeutics Inc, Dba Ev3 Neurovascular
    FEI Number
    3004904811
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 23, 2011
    Posted
    September 27, 2012
    Terminated
    September 28, 2012
    Address
    9775 Toledo Way, Irvine, CA, 92618-1811

    Description

    UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.

    Reason

    The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.

    Action

    Micro Therapeutics Inc, Dba Ev3 Neurovascular sent a recall notification letter dated September 23, 2011 to all their affected customers. The letter identified the affected product, problem, and actions to be taken. The notification letter also provides the customer (physician) with appropriate information regarding the affected products. The letter instructs customer to stop using the affected product, segregate from inventory and return for replacement with conforming product. The notice requests the customer to complete and return the reply form indicating use or return of devices in the affected lot(s). Customers with questions regarding the recall letter were instructed to contact Kim Salceda at (949) 680-1305.

    Distribution

    Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.

    Quantity

    36 units