BEUDAMED
    FDA Recall Terminated

    Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.

    Recall: Z-1019-2013 · Initiated March 13, 2013

    Recall

    Recall Number
    Z-1019-2013
    Event Number
    64623
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    FEI Number
    2182208
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    March 13, 2013
    Posted
    March 28, 2013
    Terminated
    February 6, 2014
    Address
    8200 Coral Sea St NE, Saint Paul, MN, 55112-4391

    Description

    Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.

    Reason

    Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.

    Action

    Medtronic sent an Urgent Medical Device Recall letter dated March 2013 to all affected customers. The letter identifies the affected product, problem and actions to be taken. Customers were instructed to immediately quarantine all affected products and returned to Medtronic. Customers were requested to complete the attached Customer Confirmation Certificate and fax it to Medtronic to the attention of Customer Focused Quality. For question contact your local Medtronic representative or Medtronic Customer Service at 1-888-283-7868.

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Israel, Italy, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Viet Nam.

    Quantity

    27,682 devices