BEUDAMED
    FDA Recall Open, Classified

    Azure S DR MRI SureScan, Product number W3DR01

    Recall: Z-1924-2025 · Initiated April 29, 2025

    Recall

    Recall Number
    Z-1924-2025
    Event Number
    96722
    Firm
    Medtronic, Inc.
    FEI Number
    2182208
    Product Code
    NVZ
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    April 29, 2025
    Posted
    June 6, 2025
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Azure S DR MRI SureScan, Product number W3DR01

    Reason

    Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.

    Action

    Firm notified consignees of the recall on April 29, 2025 via letters titled "Urgent Medical Device Recall". Customers were instructed to identify the affected product and return to Medtronic. If you have any questions regarding this communication, please contact your Medtronic Field Representative ***Updated 10/14/25*** Firm expanded action to include three implanted devices. Consignees were notified on September 29, 2025. Consignees were instructed to utilize the CareLink remote monitoring system and inform a Medtronic Representative if a return of patient symptoms occurs or any unexpected device behaviors occur, including but not limited to: device resets or unexpected pacing diagnostics, with or without an alert. If the clinician assesses that prophylactic replacement of the device is necessary, standard warranty will apply. Medtronic will provide a replacement Azure S DR and a TYRXTM absorbable antibacterial envelope at no cost.

    Distribution

    International distribution of the country of UK. No US distribution.

    Quantity

    6