BEUDAMED
    FDA Recall Terminated

    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.

    Recall: Z-1139-2009 · Initiated February 12, 2009

    Recall

    Recall Number
    Z-1139-2009
    Event Number
    51287
    Firm
    Medtronic Neurosurgery
    FEI Number
    3015531529
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 12, 2009
    Posted
    March 27, 2009
    Terminated
    November 8, 2010
    Address
    125-B Cremona Dr, Goleta, CA, 93117

    Description

    Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized.

    Reason

    The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

    Action

    An Urgent - Medical Device Recall notification was sent on February 13,2009 to the attention of risk managers, advising them to cease use of the Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782 ( all versions and all lot numbers), the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27802 ( all versions and all lot numbers), and the Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27708 ( all version and all lot numbers). Each customer is to cease the use of the listed product and any unused unit needs to be returned to Medtronic. Further, each account is required to account for product used/implanted and to advise surgeons of the recall information. Each account will recieved an individualized Customer Product Reconciliation Form provided by their Medtronic Sales Representative for determining the status of any product shipped to them.

    Distribution

    Worldwide Distribution -- USA, Ireland, and Australia.

    Quantity

    3048 of all units