BEUDAMED
    FDA Enforcement Class II Terminated

    FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are 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. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

    Recall: Z-0655-2013 · Reported January 16, 2013

    Enforcement

    Recall Number
    Z-0655-2013
    Event ID
    63938
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Concentric Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 16, 2013
    Initiation Date
    December 20, 2012
    Classification Date
    January 8, 2013
    Termination Date
    February 5, 2013
    Address
    301 E Evelyn Ave, Mountain View, CA, 94041-1530, United States

    Description

    FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are 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. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

    Reason

    Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Balloon Guide Catheters during use for aspiration.

    Code Info

    Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.

    Distribution

    US (nationwide) including the states of CA, FL, GA, OR and TN.

    Quantity

    13 units