BEUDAMED
    FDA Recall 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 · Initiated June 6, 2017

    Recall

    Recall Number
    Z-2863-2017
    Event Number
    77474
    Firm
    Spectranetics Corporation
    FEI Number
    3007284006
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 6, 2017
    Posted
    July 14, 2017
    Terminated
    July 8, 2021
    Address
    9965 Federal Drive, Colorado Springs, CO, 80921-3617

    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.

    Action

    Spectranetics sent a Field Safety Notice letter via certified mail on June 7, 2017, to all customers who have ordered the affected model numbers since 23May2016 reiterating the risks associated with off-label use of the device (i.e., not activating the laser within a stent and not until all contrast media is flushed from the treatment area). The product continues to meet specifications and does not need to be returned. Customers with questions were encouraged to call their local Spectranetics Sales Representative or Spectranetics Customer Service Department. Customer Service can be reached by phone at 800-231-0978 (Option 2), by fax at 877-447-2022, or by email at [email protected]. Customer Service is available Monday thru Friday, From 7AM-5PM MST.

    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