BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290

    Recall: Z-2159-2021 · Reported August 4, 2021

    Enforcement

    Recall Number
    Z-2159-2021
    Event ID
    88272
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 4, 2021
    Initiation Date
    July 9, 2021
    Classification Date
    July 28, 2021
    Address
    7000 Central Ave Ne, N/A, Minneapolis, MN, 55432-3568, United States

    Description

    Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290

    Reason

    Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.

    Code Info

    a) 977A260, PIN 977A20024V, UDI 00763000324353 b) 977A275, PIN 977A20025V, UDI 00763000324360 c) 977A290, PIN 977A20028V, UDI 00763000324377

    Distribution

    Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom

    Quantity

    1131 units