BEUDAMED
    FDA Recall Terminated

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    Recall: Z-1747-2014 · Initiated March 31, 2014

    Recall

    Recall Number
    Z-1747-2014
    Event Number
    68279
    Firm
    NEO METRICS, INC.
    FEI Number
    3003631559
    Product Code
    OCY
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 31, 2014
    Posted
    June 10, 2014
    Terminated
    January 16, 2015
    Address
    2605 Fernbrook Ln N, Ste J, Plymouth, MN, 55447-4756

    Description

    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

    Reason

    Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury.

    Action

    NeoMetrics sent a letter dated March 31, 2014, to Boston Scientific. On March 24, 2014, Boston Scientific made NeoMetrics aware that Boston Scientific received 3 complaints from customers that the tip of the NovaGold guidewire detached and/or became uncoiled. Because the tips are breaking and/or uncoiling at a rate that was not anticipated, it has been decided that these units should be removed from the field. Therefore, NeoMetrics does not object to Boston Scientific executing this product removal in accordance with Section 4.4 of the distribution agreement. For further questions please call (763) 559-4440.

    Distribution

    Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.

    Quantity

    1256 boxes ( 2 wires/box)