BEUDAMED
    FDA Recall Open, Classified

    Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;

    Recall: Z-2169-2025 · Initiated June 18, 2025

    Recall

    Recall Number
    Z-2169-2025
    Event Number
    97130
    Firm
    Medtronic, Inc.
    FEI Number
    2182208
    Product Code
    NVZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 18, 2025
    Posted
    July 23, 2025
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia AF application, Software Model Number D00U011; 5. Viva Brava Evera application, Software Model Number D00U012;

    Reason

    In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

    Action

    An URGENT MEDICAL DEVICE CORRECTION NOTIFICATION letter dated 6/18/25 was sent to customers. Customer Actions: "Update SmartSync (to version 4.2.3 or higher). Refer to release notes provided by your local Medtronicrepresentative for update instructions. If needed, Medtronic representatives are available to work with you toinstall or update the SmartSync application(s) on your tablet. See Appendix for instructions on how to verify thesoftware update is complete. "Sign and return the enclosed confirmation form and share this notice with those who need to be aware withinyour organization or with any organization where SmartSync may be in use. Questions regarding this informationshould be directed to the local Medtronic Representative or Medtronic Programmer Technical Services at 800-638-1991, Option 1.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    22091 total devices