BEUDAMED
    FDA Recall Terminated

    MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.

    Recall: Z-1370-2011 · Initiated January 26, 2011

    Recall

    Recall Number
    Z-1370-2011
    Event Number
    57850
    Firm
    St. Jude Medical Cardiovascular Division
    FEI Number
    2182269
    Product Code
    DWS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 26, 2011
    Posted
    February 17, 2011
    Terminated
    May 31, 2012
    Address
    14901 Deveau Pl, Minnetonka, MN, 55345-2126

    Description

    MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1; A0032/1; A0033/1, Cardio Life Research s.a., Green Hill, Hoge Wei, 16, B-1930 Zaventem, Belgium. Indicted for the retraction of the atrium walls during mitral or tricuspid cardiac surgery.

    Reason

    St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers of the MitraXs Self Adjusting Atrial Retractor. St. Jude Medical has been distributing this product since their acquisition of CLR in late 2008. They have determined that some distributed batches have very small burrs on the polycarbonate material at the distal edge. As these burrs may

    Action

    The firm, St. Jude Medical, sent an "Urgent Medical Device Recall Notice" dated January 26, 201,1 to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue use of the product (MitraXs Self Adjusting Atrial Retractor batches) and remove from inventory. St. Jude began production of a new batch of units that will bear the labeling of St. Jude Medical. Shipment of these units started on January 10, 2011. Note: A St. Jude Medical Sales Representative will contact the customer to facilitate removal and reconciliation of the affected product. If you have any questions or concerns, please contact your St. Jude Medical Sales Representative or 651-490-4470 and/or 612-310-7936.

    Distribution

    Worldwide distribution: USA including states of: NJ, OH, MI, and MN; and countries including: BELGIUM, FRANCE, GERMANY, SWITZERLAND, and UNITED KINGDOM.

    Quantity

    450