BEUDAMED
    FDA Enforcement Class II Terminated

    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions

    Recall: Z-2863-2017 · Reported August 9, 2017

    Enforcement

    Recall Number
    Z-2863-2017
    Event ID
    77474
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spectranetics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 9, 2017
    Initiation Date
    June 6, 2017
    Classification Date
    August 2, 2017
    Termination Date
    July 8, 2021
    Address
    9965 Federal Drive, N/A, Colorado Springs, CO, 80921-3617, United States

    Description

    Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions

    Reason

    Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.

    Code Info

    Model Number 414-159 Catheter Diameter 1.4mm, Model Number 417-156 Catheter Diameter 1.7mm, and Model Number 420-159 Catheter Diameter 2.0mm.

    Distribution

    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico Foreign distribution to Bahrain, Brazil, Canada, Italy, Japan, and Netherlands

    Quantity

    N/A