BEUDAMED
    FDA Recall 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 · Initiated January 5, 2012

    Recall

    Recall Number
    Z-2309-2012
    Event Number
    61451
    Firm
    Cook Ireland Ltd. O'holloran Road, National Technological Park Limerick, Peroc Ireland
    FEI Number
    3001845648
    Product Code
    NIO
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 5, 2012
    Posted
    September 1, 2012
    Terminated
    February 4, 2013

    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

    Action

    The firm, Cook Medical, sent a letter dated February 13, 2012 to foreign consignee. The letter described the product, problem and actions taken. The firm stated that re-training of the relevant personnel has been carried out; they will continue to monitor to identify potential emerging trends and further corrective and preventive action will be considered in an effort to avoid the recurrence of similar events. If you have any question contact in US: Customer Relations Manager at 800.346.2686.ext 2222 or email: [email protected]; OUS: Customer Quality Supervisor at +353 61 239343.

    Distribution

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

    Quantity

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