BEUDAMED
    FDA Recall Terminated

    Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland

    Recall: Z-0358-2011 · Initiated August 24, 2009

    Recall

    Recall Number
    Z-0358-2011
    Event Number
    53048
    Firm
    Boston Scientific Corporation
    FEI Number
    2939204
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 24, 2009
    Posted
    November 15, 2010
    Terminated
    February 3, 2011
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515

    Description

    Boston Scientific brand Renegade Fiber Braided Microcatheter, 150/10/2RO, Rx Only; Model Numbers: 18257, 18259; Product is distributed by Boston Scientific Corporation, Natick, MA; Product is manufactured by Boston Scientific Corporation, Cork, Ireland

    Reason

    Sterility Loss-- The sterile barrier pouch seal (top seal) may be breached by the product, resulting in loss of sterility which may result in transmission of disease or infection.

    Action

    Boston Scientific issued an Urgent Medical Device Recall letter dated August 26, 2009 identifying the affected devices, the issue prompting the recall, and actions to be taken by customers. Customers were instructed to determine if they have affected product in their inventory, and if so, immediately quarantine and return to Boston Scientific. Customers can contact Boston Scientific at 510 624-1734.

    Distribution

    Distribution Worldwide, including throughout the US.