BEUDAMED
    FDA Recall Open, Classified

    Medtronic, Simplera Sensor, REF: MMT-5100JD1

    Recall: Z-0033-2026 · Initiated May 7, 2025

    Recall

    Recall Number
    Z-0033-2026
    Event Number
    96745
    Firm
    Medtronic MiniMed, Inc.
    FEI Number
    3003166194
    Product Code
    MDS
    Status
    Open, Classified
    Root Cause
    Process design
    Initiated
    May 7, 2025
    Posted
    October 2, 2025
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    Medtronic, Simplera Sensor, REF: MMT-5100JD1

    Reason

    The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

    Action

    On May 7, 2025, Medtronic issued a "Urgent Field Safety Notice" to affected consignees. Medtronic asked consignees to take the following actions: 1. Verify if the sensors you currently have are from the impacted lot. 2. If you have a Simplera" sensor from the impacted lot, do not use this Simplera" sensor and dispose of it according to local regulations. 3. Please contact our helpline/your Medtronic contact at 01923 205167 to request a replacement. 4. Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter, even if your sensor is unaffected, or if you do not have any sensors from the affected lot.

    Distribution

    US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom

    Quantity

    1,440 units