BEUDAMED
    FDA Recall Open, Classified

    InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

    Recall: Z-1650-2025 · Initiated March 4, 2025

    Recall

    Recall Number
    Z-1650-2025
    Event Number
    96421
    Firm
    Medtronic MiniMed, Inc.
    FEI Number
    3003166194
    Product Code
    FMF
    Status
    Open, Classified
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 4, 2025
    Posted
    April 21, 2025
    Address
    18000 Devonshire St, Northridge, CA, 91325-1219

    Description

    InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA

    Reason

    Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.

    Action

    On 3/4/2025, correction notices were sent to customers and distributors informing them of the following: 1) If you have already inserted your insulin cartridge into your device without difficulty removing the cartridge holder, then you can continue normal use. 2) If you have a device from one of the affected lot numbers and have not yet started using it, or have had difficulties in removing the cartridge holder or inserting the insulin cartridge, please call 1-800-646-4633, option 1, or go to https://info.medtronicdiabetes.com/ICH-replacement-form to request a replacement product. Do not use this device and dispose of it according to local regulations. 3) Complete and return the confirmation form via link: https://info.medtronicdiabetes.com/cartridge-holder Distributors are asked to notify impacted customers. If you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 1-800-646-4633, option 1.

    Distribution

    US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH, VA, NY, TN, HI, MA, NJ, PA, CO, WI, GA, CT, NE, OR, LA, NM, SD, ND, IN, NV, WV, RI, AR, NH

    Quantity

    8,986