BEUDAMED
    FDA Recall Terminated

    AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.

    Recall: Z-1101-2010 · Initiated December 18, 2009

    Recall

    Recall Number
    Z-1101-2010
    Event Number
    54369
    Firm
    AGA Medical Corporation
    FEI Number
    3005334138
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    December 18, 2009
    Posted
    March 11, 2010
    Terminated
    March 29, 2012
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    Description

    AGA Medical Corporation, Amplatzer TorqVue Delivery System 45-degree. REF: 9-1TV10F45/80. Designed to facilitate the introduction of transvenous devices to chambers and coronary vasculature of the heart and for introducing therapeutic devices to a location within the peripheral vasculature.

    Reason

    In this lot of TorqVue Delivery Systems (PN: 9-ITV10F45/80, LN: 0906151781), the dilator cannot be fully secured to the sheath as directed by the instructions for use.

    Action

    An AGA Medical Product Recall Notice, dated December 18, 2009 was sent to customers on 12/18/2009. The letter identified the affected product, described the issue and asked for devices to be returned. Customers are asked to complete a form attached to the product recall notice and return it to AGA via fax or email.

    Distribution

    Worldwide distribution: USA, Colombia, Greece, Italy, Japan, Mexico, Slovakia, and Taiwan.

    Quantity

    57