BEUDAMED
    FDA Enforcement Class I Ongoing

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    Recall: Z-1164-2024 · Reported March 6, 2024

    Enforcement

    Recall Number
    Z-1164-2024
    Event ID
    93919
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Neurosurgery
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2024
    Initiation Date
    January 22, 2024
    Classification Date
    February 27, 2024
    Address
    5290 California Ave, Irvine, CA, 92617-3073, United States

    Description

    Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    Reason

    Potential for catheter disconnection from the patient line stopcock connectors.

    Code Info

    Lot Number/GTIN: 221604935 00613994445384; 221827829 00613994445384; 222121359 00613994445384; 222125124 00613994445384; 222163140 00613994445384 222163787 00613994445384; 222163788 00613994445384; 222204095 00613994445384; 222204097 00613994445384; 222439027 00613994445384; 222439028 00613994445384; 222439029 00613994445384 222658560 00613994445384; 222658561 00613994445384; 222724791 00613994445384; 222724792 00613994445384; 222766469 00613994445384; 222766470 00613994445384; 222816525 00613994445384; 222817386 00613994445384; 222817387 00613994445384 223818451 00763000624781; 223818452 00763000624781; 223954944 00763000624781; 223956932 00763000624781; 224083877 00613994445384; 224303373 00613994445384; 224303374 00613994445384; 225336444 00613994445384; 225468102 00613994445384; 226242272 00763000624781; 226366038 00613994445384; 226420633 00613994445384; 226420634 00763000624781; 226490981 00613994445384; 226517901 00613994445384; 226546796 00763000624781; 226571114 00763000624781; 226625848 00763000624781; 226632942 00763000624781; 226634688 00763000624781; 226634689 00763000624781; 226634690 00763000624781; 226665393 00763000624781; 226665394 00613994445384; 226665399 00763000624781; 226665400 00763000624781; 226665401 00763000624781; 226665403 00763000624781; 226665404 00763000624781; 226665405 00763000624781; 226665646 00763000624781; 226665647 00763000624781; 226665648 00763000624781; 226665650 00763000624781; 226732001 00763000624781; 226899377 00613994445384; 226951465 00613994445384; 226951467 00613994445384; 226951468 00613994445384; 226951469 00763000396008; 227136777 00763000624781; 227188108 00763000624781; 227194735 00763000624781; 227194736 00763000624781

    Distribution

    Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV; and OUS (foreign): Argentina, Australia, Bahrain, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Curacao, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, Gabon, Germany, Ghana, Greece, Hong Kong, Iceland, Iran, Islamic Republic Of Ireland, Italy, Kazakhstan, Kuwait, Latvia, Malaysia, Malta, Mauritius, Mexico, Namibia, Netherlands, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.

    Quantity

    14,139 units