BEUDAMED
    FDA Recall Terminated

    12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.

    Recall: Z-1395-2012 · Initiated March 13, 2012

    Recall

    Recall Number
    Z-1395-2012
    Event Number
    61408
    Firm
    Spectranetics Corp.
    FEI Number
    3007284006
    Product Code
    LPC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 13, 2012
    Posted
    April 11, 2012
    Terminated
    May 2, 2012
    Address
    9965 Federal Drive, Colorado Springs, CO, 80921-3617

    Description

    12Fr SLS II Laser Sheath. The laser sheath is intended for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.

    Reason

    Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.

    Action

    Spectranetics sent Recall Notices to all customers on March 14, 2012. The product issue was described and requested actions were included. Questions were directed to Customer Service at 1-800-231-0978 (US).

    Distribution

    Worldwide Distribution -- USA , and the countries of Australia, Belgium, Canada, Czech Republic, France, Germany, Italy, Ireland, Japan, Netherlands, Russia, Sweden, Switzerland, United Kingdom and Venezuela.

    Quantity

    615