BEUDAMED
    FDA Recall Open, Classified

    CareLink Clinic, REF: MMT-7350

    Recall: Z-0594-2026 · Initiated October 21, 2025

    Recall

    Recall Number
    Z-0594-2026
    Event Number
    97873
    Firm
    Medtronic MiniMed, Inc.
    FEI Number
    3003166194
    Product Code
    PHV
    Status
    Open, Classified
    Root Cause
    Software change control
    Initiated
    October 21, 2025
    Posted
    November 25, 2025
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    CareLink Clinic, REF: MMT-7350

    Reason

    Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.

    Action

    On 10/21/2025, "URGENT MEDICAL DEVICE CORRECTION" notices were emailed to customers informing them of the following: software version 4.2C was released to correct the issues with the data displayed on 24-hour Sensor Glucose Overview graph. If you made individual diabetes treatment recommendations to patients based on the hypoglycemic patterns or on the 30-day sensor glucose data displayed on the 24-hour Sensor Glucose Overview graph with affected software, revisit those recommendations utilizing patients individual CareLink reports, as they were not impacted by this issue. Complete and return the confirmation form: https://info.medtronicdiabetes.com/carelink-clinic-dashboard-hcp or email form to [email protected] For questions, contact the firm's 24-Hour Technical Support line at 1-800-646-4633, option 9.

    Distribution

    Worldwide Distribution: US (nationwide) including states of: TX, NC, MN, CA, VA, ID, WA, GA, MI, MA, OH, IL, IA, CT, FL, PA, NY, TN, AZ, LA, AL, NJ, CO, SC, MS, OR, MT, MD, KS, AK, NH, NE, WY, ND, IN, MO, WI, KY, UT, NV, SD, WV, NM, HI, AR, OK, VT, RI; and OUS (foreign) to countries of: Australia (AU), Sweden (SE), Belgium (BE), Great Britain (GB), Netherlands (NL), Finland (FI), Canada (CA), Germany (DE), Spain (ES), Switzerland (CH), Italy (IT), South Africa (ZA), South Korea (KR), Singapore (SG), New Zealand (NZ), Poland (PL), Israel (IL), Denmark (DK), Norway (NO), Luxembourg (LU), Lithuania (LT), Czech Republic ( CZ), Mexico (MX), Brazil (BR), Colombia (CO), Slovakia (SK), Ireland (IE), Argentina (AR), Greece (GR), Kuwait (KW), Portugal (PT), Iceland (IS), Japan (JP), Turkey (TR), Austria (AT), Qatar (QA), Hong Kong (HK), Chile (CL), Ukraine (UA), Hungary (HU), Estonia (EE), RS, Latvia (LV), Taiwan (TW), Saudia Arabia (SA), Bahrain (BH), Oman (OM), Romania (RO), India (IN), Uruguay (UY), Malaysia (MY), United Arab Emirates (AE), Algeria (DZ), Croatia (HR), France (FR), Russia (RU), Cyprus (CY), Thailand (TH), Egypt (EG), Bosnia and Herzegovina (BA), Libya (LY), and Iraq (IQ)

    Quantity

    12126