BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.

    Recall: Z-0398-2014 · Reported December 4, 2013

    Enforcement

    Recall Number
    Z-0398-2014
    Event ID
    66882
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neurosurgery
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2013
    Initiation Date
    November 18, 2013
    Classification Date
    November 26, 2013
    Termination Date
    February 6, 2014
    Address
    125 Cremona Dr, N/A, Goleta, CA, 93117-3083, United States

    Description

    Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.

    Reason

    Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

    Code Info

    Lot Numbers: D01859; D11969; D15985; D25462; D37523; D42401.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.

    Quantity

    34 units