BEUDAMED
    FDA Recall Terminated

    Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems

    Recall: Z-1586-05 · Initiated August 8, 2005

    Recall

    Recall Number
    Z-1586-05
    Event Number
    33117
    Firm
    Guidant Endovascular Solutions, Inc.
    FEI Number
    2024168
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 8, 2005
    Posted
    September 24, 2005
    Terminated
    July 31, 2012
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems

    Reason

    This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter.

    Action

    (1 )Identify all customers world wide who have been shipped affected product from 01/01/2003 through 08/03/2005. (2)Contact and coordinate with LA District FDA Recall Coordinator, KEMA Notified Body, and other Competent Authorities outside the US as mandated by country local law. (3)Deliver Physiciam Medical Device recall Notice and Reconciliation Form via Federal Express in US/Mexico/ Puerto Rico. (4)Reconcile receipt notification and physical product returns to expected returns.

    Distribution

    Nationwide and Argentina, Austria, Bahrain, Belgium, Brazil, Bulgaria, Chile, Czech Republic, Dominican Republic, Findland, France, Germany, Greece, Hungary, Israel, Italy, Jordan, Lebanon, Malta, Mexico, Netherlands, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, South Africa, Spain, Tunisia, Turkey, United Arab Emirates, & United Kingdom.

    Quantity

    69,700