BEUDAMED
    FDA Recall Terminated

    Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.

    Recall: Z-2028-2009 · Initiated April 16, 2009

    Recall

    Recall Number
    Z-2028-2009
    Event Number
    52810
    Firm
    Cardiovascular Systems, Inc.
    FEI Number
    3004742232
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    April 16, 2009
    Posted
    September 10, 2009
    Terminated
    December 10, 2011
    Address
    651 Campus Dr, Arden Hills, MN, 55112-3495

    Description

    Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.

    Reason

    CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distributed products recognizing the valid s

    Action

    Cardiovascular System, Inc. issued an "URGENT: Medical Device Correction" letter dated April 16, 2009. The letter described the product and the problem. The letter informed the consignees that the "Device" re-labeling would be performed by company representatives. Devices will not be returned. For further information, contact Cardiovascular System, Inc. 1-877-274-0901.

    Distribution

    Nationwide Distribution -- CA, GA, MI, NY, NY and TN.

    Quantity

    8