BEUDAMED
    FDA Recall Terminated

    Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant duration of 7 days or less. The system is used with Medtronic temporary external pacemakers.

    Recall: Z-2200-2016 · Initiated June 16, 2016

    Recall

    Recall Number
    Z-2200-2016
    Event Number
    74424
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure
    FEI Number
    2182208
    Product Code
    LDF
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 16, 2016
    Terminated
    February 13, 2018
    Address
    8200 Coral Sea St NE, Mounds View, MN, 55112-4391

    Description

    Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog Numbers: Five (5) Pack Single Pack 6416-100 6416-1005 6416-140 6416-1405 6416-200 6416-2005 For temporary intracardiac pacing and EGM recording. The system is disposable, for temporary single patient use, with a contemplated implant duration of 7 days or less. The system is used with Medtronic temporary external pacemakers.

    Reason

    This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of FDA 21 CFR 898, which relate to design standards to prevent connecting a patients lead to a possible hazardous voltage.

    Action

    Medtronic sent an Urgent Medical Device Recall letter dated June 2016 to affected customers. The letter was addressed to Health Care Professional. The letter described the problem and the product involved in the recall. The letter described the "Customer Actions" which advised consignees to identify, quarantine and return affected product to Medtronic. Customers were instructed to complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and e-mail to [email protected]. For questions, please contact your Medtronic CRHF Sales Representative.

    Distribution

    Worldwide Distribution. US nationwide, Albania, Algeria, Australia, Botswana, Bulgaria, Canada, Colombia, France, Gabon, Germany, Guam, Hong Kong, Hungary, Ireland, Israel, Italy, Jordan, Kazakhstan, Macedonia, Mauritius, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, St Maarten, Sweden, Switzerland, Tajikistan, Turkey, Uganda, United Arab Emirates, United Kingdom, and US Virgin Islands.

    Quantity

    11697 (5523 OUS, 6174 US)