BEUDAMED
    FDA Recall Terminated

    St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.

    Recall: Z-0933-2007 · Initiated March 20, 2007

    Recall

    Recall Number
    Z-0933-2007
    Event Number
    37818
    Firm
    St Jude Medical CRMD
    FEI Number
    2017865
    Product Code
    MCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 20, 2007
    Posted
    June 14, 2007
    Terminated
    February 29, 2012
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    St. Jude Medical-CPS Direct SL- slittable CRT lead delivery tool. -Model Numbers 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120,410121. 410122, 410123, 410124, 410125 and 410126.

    Reason

    Device Separation- product may separate at the mapping collar transition joint located at the proximal (light blue) marker band end of the tool during the implant procedure.

    Action

    By Letter dated March 20, 2007, customers were requested to returned affected product immediately to St. Jude Medical. St. Judes Sales Representative will be assisting customers in retrieving the subject inventory from their shelves. The firm instructed customers that if they should require further information regarding this issue, to contact the firm's Technical Service department at (800) 722-3774 or customers can contact local St. Jude Medical representative.

    Distribution

    Worldwide-including states of AZ, CA DC, FL GA, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NH, NY, OH, PA, RI, TN, VA, and WI and countries of Austria, Belgium, Denmark, Finland, Netherlands, Sweden, France, Germany, Italy, UK, Spain, Portugal, Poland, Switzerland, Australia, New Zealand, Thailand, Hong Kong, Korea, Malaysia and Singapore.

    Quantity

    14,000