BEUDAMED
    FDA Recall Open, Classified

    REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

    Recall: Z-0872-2021 · Initiated December 16, 2020

    Recall

    Recall Number
    Z-0872-2021
    Event Number
    87069
    Firm
    Medtronic Neurosurgery
    FEI Number
    3015531529
    Product Code
    JXG
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    December 16, 2020
    Address
    5290 California Ave, Irvine, CA, 92617-3073

    Description

    REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity.

    Reason

    Neonatal Valves were manufactured with a ventricular catheter connection site shorter than the design specification. The defect can lead to difficulty in securing the valve to the proximal catheter which could result in disconnection of the ventricular catheter from the valve and shunt malfunction

    Action

    On 12/16/2020, Medtronic sent a "URGENT: MEDICAL DEVICE RECALL" notification to affected customers via FedEx. In addition, to notifying consignees about the recall, the firm ask consignees to take the following actions: 1. Identify, segregate, and quarantine affected valves within your inventory. 2. Contact Medtronic to return affected valves and receive replacement(s). See instructions below. 3. Please complete and return the customer confirmation form, even if you do not have any affected valves. 4. Return the form via email to [email protected] or via fax to 651-367-7075 within 30 days of receipt.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IL, KS, KY, LA, MA, MI, MO, NV, NM, NY, ND, OH, OK, TN, VA and the countries of Albania, Australia, Brazil, Cyprus, Ireland, Mexico, Qatar, Romania, Russian Federation, Serbia, South Africa, Spain, United Kingdom.