BEUDAMED
    FDA Enforcement Class I Terminated

    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.

    Recall: Z-1923-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1923-2014
    Event ID
    68503
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Neurosurgery
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    June 9, 2014
    Classification Date
    June 27, 2014
    Termination Date
    January 14, 2015
    Address
    125 Cremona Dr, Goleta, CA, 93117-3083, United States

    Description

    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.

    Reason

    Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.

    Code Info

    Lot No. 206843114 206854302 206923345 207167085 207246211 207466015 207565607 207716842 207766492 208031202

    Distribution

    Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.

    Quantity

    1,187 units