BEUDAMED
    FDA Enforcement Class I 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 · Reported January 29, 2014

    Enforcement

    Recall Number
    Z-0789-2014
    Event ID
    66493
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codman & Shurtleff, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 29, 2014
    Initiation Date
    October 11, 2013
    Classification Date
    January 23, 2014
    Termination Date
    July 28, 2015
    Address
    325 Paramount Drive, Raynham, MA, 02767, United States

    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).

    Code Info

    All lot codes

    Distribution

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

    Quantity

    7,983