BEUDAMED
    FDA Recall Terminated

    Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.

    Recall: Z-0899-2011 · Initiated February 27, 2009

    Recall

    Recall Number
    Z-0899-2011
    Event Number
    51401
    Firm
    Concentric Medical Inc
    FEI Number
    3003271051
    Product Code
    GBS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 27, 2009
    Posted
    January 12, 2011
    Terminated
    January 13, 2011
    Address
    301 E Evelyn Ave, Mountain View, CA, 94041-1530

    Description

    Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.

    Reason

    Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.

    Action

    Concentric Medical products sent an URGENT VOLUNTARY MEDICAL DEVICE REMOVAL letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and identify any affected product. Quarantine the product and call Concentric Medical Customer Service at 877-471-0076 (USA toll-free) or 650-938-2100 to receive instructions for returning the devices. For questions regarding this recall call 877-471-0076.

    Distribution

    Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland

    Quantity

    36 units affected.