BEUDAMED
    FDA Recall Terminated

    FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS

    Recall: Z-0792-2011 · Initiated October 11, 2010

    Recall

    Recall Number
    Z-0792-2011
    Event Number
    56965
    Firm
    Arrow International, Inc., Division of Teleflex Medical Inc.
    FEI Number
    3010532612
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 11, 2010
    Posted
    December 23, 2010
    Terminated
    February 5, 2015
    Address
    9 Plymouth St, Everett, MA, 02149-1814

    Description

    FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS

    Reason

    SuperArrow Flex IAB catheter becomes stuck in the sheath, unable to move the IAB catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.

    Action

    Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.

    Distribution

    Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.

    Quantity

    12, 261 units