BEUDAMED
    FDA Recall Terminated

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. 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-1924-2014 · Initiated June 9, 2014

    Recall

    Recall Number
    Z-1924-2014
    Event Number
    68503
    Firm
    Medtronic Neurosurgery
    FEI Number
    3015531529
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 9, 2014
    Posted
    June 27, 2014
    Terminated
    January 14, 2015
    Address
    125 Cremona Dr, Goleta, CA, 93117-3083

    Description

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. 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.

    Action

    An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.

    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

    35 units