BEUDAMED
    FDA Recall Terminated

    CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire guides, coils, balloons, catheters, and filters.

    Recall: Z-2243-2014 · Initiated July 17, 2014

    Recall

    Recall Number
    Z-2243-2014
    Event Number
    68914
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    MMX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 17, 2014
    Posted
    August 27, 2014
    Terminated
    June 16, 2015
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including but not limited to, wire guides, coils, balloons, catheters, and filters.

    Reason

    This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.

    Action

    Cook Medical sent an Urgent Medical Device Recall letter dated July 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the attached list of affected products and lot numbers shipped to their account, and quarantine any affected product that remains unused. Immediately collect and return all unused affected products to Cook Medical as soon as possible for credit. Complete the attached Recalled Product Reply Form and return to Cook Medical either with the product or separately. Customers were asked to report any Adverse Event to Cook Medical Customer Relations at 800-457-4500 or 1-812-339-2235.

    Distribution

    Worldwide Distribution - USA including AK, AL, AZ, CA, CT, DC, FL, GA, HI, IA, ID, IL, IN, KY, LA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TX, UT, VA, WA, WI, WV and Internationally to: Canada, Austria, Belgium, Denmark, Germany, Great Britain, Ireland, Italy, Spain, Sweden, and Switzerland.

    Quantity

    696 devices total distribution (671 nationwide)