BEUDAMED
    FDA Recall Open, Classified

    Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

    Recall: Z-0354-2024 · Initiated October 19, 2023

    Recall

    Recall Number
    Z-0354-2024
    Event Number
    93303
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Software Manufacturing/Software Deployment
    Initiated
    October 19, 2023
    Posted
    November 20, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

    Reason

    Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.

    Action

    Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees via regionally approved method beginning 10/19/2023. The notice explained the issue, potential risk to the patient, and requested the return of the units.

    Distribution

    International distribution to the countries of S. Korea and Turkey.

    Quantity

    26 units