BEUDAMED
    FDA Recall Terminated

    Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in the recall. The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

    Recall: Z-2946-2011 · Initiated July 11, 2011

    Recall

    Recall Number
    Z-2946-2011
    Event Number
    59368
    Firm
    Vascular Solutions, Inc.
    FEI Number
    3002827704
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 11, 2011
    Posted
    August 4, 2011
    Terminated
    April 3, 2012
    Address
    6464 Sycamore Ct N, Maple Grove, MN, 55369-6032

    Description

    Vascular Solutions, Pronto V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in the recall. The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

    Reason

    Vascular Solutions , Inc recently discovered that there was a manufacturing defect with Pronto V4 extraction catheters (Models 4005, 4006, 4007, 4008). Use of this defective product could lead to a tip separation. This may cause injury and/or procedural delay, resulting in a deteriorating hemodynamic condition of the patient which may require medical intervention.

    Action

    Vascular Solutions, Inc. sent an "URGENT: MEDICAL DEVICE FIELD ACTION" letter dated July 8, 2011 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify the affected product and remove from current inventory. Included with the letter was a Field Action Customer Inventory Form for customers to complete and return. VSI will contact customers for replacement product upon receipt of the form and returned product. Contact your local representative for questions concerning this notice.

    Distribution

    Nationwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, FL, ID, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK ,OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.

    Quantity

    1086