BEUDAMED
    FDA Recall Terminated

    TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

    Recall: Z-0889-2011 · Initiated December 2, 2010

    Recall

    Recall Number
    Z-0889-2011
    Event Number
    57414
    Firm
    Cardiac Assist, Inc
    FEI Number
    3002228812
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2010
    Posted
    January 10, 2011
    Terminated
    December 1, 2011
    Address
    240 Alpha Dr, Pittsburgh, PA, 15238-2906

    Description

    TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

    Reason

    Component (Dilator of TandemHeart Transseptal Cannula Set-EF) does not meet specifications

    Action

    CardiacAssist, Inc. sent a Voluntary Recall letter dated November 12, 2010, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to examine inventory for the affected product and remove from inventory and identify it as a recalled product by applying the enclosed "CAUTION: DO NOT USE" sticker(s) and quarantine to prevent usage. Consignees were to complete the form included with the letter and fax a copy of the form to (412) 963-9739 to coordinate the return and replacement of any affected product. For questions regarding this recall call (412) 963-7770, ext. 271.

    Distribution

    Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.

    Quantity

    164