BEUDAMED
    FDA Recall Terminated

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

    Recall: Z-0789-2014 · Initiated October 11, 2013

    Recall

    Recall Number
    Z-0789-2014
    Event Number
    66493
    Firm
    Codman & Shurtleff, Inc.
    FEI Number
    3002947440
    Product Code
    KGG
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 11, 2013
    Posted
    January 23, 2014
    Terminated
    July 28, 2015
    Address
    325 Paramount Drive, Raynham, MA, 02767

    Description

    TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.

    Reason

    Incorrect instructions for use (IFU).

    Action

    The firm, CODMAN Neuro, sent a "Medical Device Correction Notice" letter dated October 21, 2013 to its consignees/customers. The letter describes the product, problem and actions taken. The letter informed the consignees/customers of the incorrect statement in the IFU. The Corrected IFU was provided. Codman Neuro is in the process of updating the Instructions for Use to include the corrected information. Consignees/customers were instructed to complete and return the Correction Notice Acknowledgement Form and fax it to Codman Neuro at 508-977-6665. For additional information, please contact Codman Neuro representative at 1-866-491-0974.

    Distribution

    Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.

    Quantity

    7,983