BEUDAMED
    FDA Recall Open, Classified

    Enhanced Verify Evaluation Handset (CFN HH90130FA)

    Recall: Z-1704-2025 · Initiated April 3, 2025

    Recall

    Recall Number
    Z-1704-2025
    Event Number
    96688
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    EZW
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    April 3, 2025
    Posted
    April 30, 2025
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Enhanced Verify Evaluation Handset (CFN HH90130FA)

    Reason

    Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

    Action

    Firm began notifying Medtronic representatives on April 3, 2025. If impacted devices were found to be with a consignee, the representative will connect with the consignee to provide a copy of the Customer Letter, obtain a signed copy of the Customer Confirmation Form, and retrieve the impacted device. Customers were informed that their Medtronic representative will collect the affected devices and arrange for replacement devices.

    Distribution

    US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI.

    Quantity

    534