BEUDAMED
    FDA Enforcement Class II Terminated

    Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.

    Recall: Z-0908-2014 · Reported February 12, 2014

    Enforcement

    Recall Number
    Z-0908-2014
    Event ID
    67242
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Cardiovascular Surgery-the Heart Valve Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2014
    Initiation Date
    January 9, 2014
    Classification Date
    February 4, 2014
    Termination Date
    May 30, 2014
    Address
    1851 E Deere Ave, Santa Ana, CA, 92705-5720, United States

    Description

    Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.

    Reason

    Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant.

    Code Info

    Model 7305. Lot/Serial Numbers: The catalog numbers for the Obturator/Sizer are 7305C, 7305UX, and 7305OD. Scope of this notification includes all Mosaic Obturators/Sizers, used with Mosaic Porcine Aortic Bioprosthesis implants.

    Distribution

    Worldwide Distribution - USA (nationwide)

    Quantity

    8276 units