BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0908-2014 · Initiated January 9, 2014

    Recall

    Recall Number
    Z-0908-2014
    Event Number
    67242
    Firm
    Medtronic Cardiovascular Surgery-the Heart Valve Division
    FEI Number
    2025587
    Product Code
    LWR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 9, 2014
    Posted
    February 3, 2014
    Terminated
    May 30, 2014
    Address
    1851 E Deere Ave, Santa Ana, CA, 92705-5720

    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.

    Action

    Medtronic sent an Customer Notification letter dated January 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Medtronic recommends surgeons continue to remain diligent in selecting the appropriate size of Mosaic Aortic Bioprosthesis. Adoption of the updated Mosaic Aortic Bioprosthesis sizing chart (iEOA chart) and Mosaic Obturators/Sizers will facilitate optimal aortic valve size selection. Your Medtronic Field Representative will be contacting you about receiving a new Mosaic Aortic Obturator/Sizer set and sizing chart. If you would prefer to order the new Mosaic Aortic Obturator/Sizer set directly through Medtronic Customer Service, contact them at 1-800-848-9300. Medtronic will notify all applicable regulatory agencies, as required, about this matter. Please share this notification with others in your organization as appropriate. We appreciate your review of this notification and apologize for the inconvenience that it may cause. If you have any questions, please contact your Medtronic Field Representative or Lifeline Technical Services at 1-877-526-7890.

    Distribution

    Worldwide Distribution - USA (nationwide)

    Quantity

    8276 units