BEUDAMED
    FDA Enforcement Class II Terminated

    Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.

    Recall: Z-2309-2012 · Reported September 12, 2012

    Enforcement

    Recall Number
    Z-2309-2012
    Event ID
    61451
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cook Ireland Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    September 12, 2012
    Initiation Date
    January 5, 2012
    Classification Date
    August 31, 2012
    Termination Date
    February 4, 2013
    Address
    O'holloran Road,, National Technological Park, Limerick, Peroc, N/A, N/A, Ireland

    Description

    Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.

    Reason

    Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35

    Code Info

    Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014

    Distribution

    Worldwide distribution: USA (nationwide) and country of: Japan.

    Quantity

    15 units of ZIV5-18-125-8-80 LOT# CF694429