BEUDAMED
    FDA Recall Terminated

    StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is manufactured by: Abbott Vascular Inc., 400 Saginaw Drive, Redwood City, CA 94063

    Recall: Z-0575-2007 · Initiated January 31, 2007

    Recall

    Recall Number
    Z-0575-2007
    Event Number
    37270
    Firm
    Abbott Vascular, Inc.
    FEI Number
    3000718335
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 31, 2007
    Posted
    March 8, 2007
    Terminated
    February 26, 2008
    Address
    400 Saginaw Dr, Redwood City, CA, 94063-4749

    Description

    StarClose Vascular Closure System (Clip Applier & Exchange System), Catalog Number: 14677; Product is manufactured by: Abbott Vascular Inc., 400 Saginaw Drive, Redwood City, CA 94063

    Reason

    Premature release of the vessel locator wings, which stabilize the device prior to clip deployment, will result in no hemostasis.

    Action

    On 1/31/07, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned to its sales rep.

    Distribution

    Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.

    Quantity

    97,952 units