BEUDAMED
    FDA Enforcement Class I Terminated

    Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

    Recall: Z-1290-2015 · Reported April 1, 2015

    Enforcement

    Recall Number
    Z-1290-2015
    Event ID
    70727
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiovascular Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 1, 2015
    Initiation Date
    March 4, 2015
    Classification Date
    March 20, 2015
    Termination Date
    April 26, 2016
    Address
    651 Campus Dr, Saint Paul, MN, 55112-3495, United States

    Description

    Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.

    Reason

    The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.

    Code Info

    107046, 106992, 106993, 106990.

    Distribution

    Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.

    Quantity

    30