BEUDAMED
    FDA Recall Open, Classified

    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

    Recall: Z-1165-2024 · Initiated January 22, 2024

    Recall

    Recall Number
    Z-1165-2024
    Event Number
    93919
    Firm
    Medtronic Neurosurgery
    FEI Number
    3015531529
    Product Code
    PCB
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 22, 2024
    Posted
    February 27, 2024
    Address
    5290 California Ave, Irvine, CA, 92617-3073

    Description

    Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, 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.

    Action

    On January 23, 2024, Medtronic CSF issued a "URGENT: MEDICAL DEVICE RECALL" Notification to affected consignees via mail. Medtronic CSF asked consignees to take the following actions: 1. Immediately identify and quarantine any unused impacted product(s). 2. Return all unused and non-expired product(s) in your inventory to Medtronic. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. 3. Work with your Medtronic Rep to receive an RGA# or contact us at 1-800-874-5797, Option 1, to coordinate inventory replacement/credit. Reference FA1400, Lot Number, and Product Number. 4. Reference the RGA# in the attention line when returning the affected product. Credit for products returned without an RGA# may be delayed. 5. Return unopened affected units to: Medtronic, Attention: [Insert RGA #], 4340 Swinnea Rd., Building B, Returns cage, Memphis, TN 38118 6. Complete and return the Customer Confirmation Form, even if you do not have any unused affected product to return via email to [email protected] within 30 days of receipt. If you have any questions regarding this communication, please contact your Medtronic representative.

    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

    11,840 units