BEUDAMED
    FDA Recall Open, Classified

    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28

    Recall: Z-2287-2025 · Initiated July 2, 2025

    Recall

    Recall Number
    Z-2287-2025
    Event Number
    97185
    Firm
    Spark Biomedical Inc
    FEI Number
    3017987352
    Product Code
    PZR
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    July 2, 2025
    Posted
    August 11, 2025
    Address
    19830 Fm 1093 Rd, Ste 401, Richmond, TX, 77407-8621

    Description

    Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28

    Reason

    Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

    Action

    On July 2, 2025, Spark Biomedical initiated a Urgent Medical Device Recall via phone. During the phone conversation, Spark Biomedical will ask consignees to take the following actions: 1. Spark Biomedical will replace all affected00 units at no cost. Even if the units appear to be working. 2. Current devices may continue to be used until they are replaced. 3. Please perform a check of the cable to patient controller connection before use. If this connection is loose or moves, please discontinue use of that patient controller device and quarantine that device until the replacement arrives. 4. Please notify all appropriate personnel at your facility that need to know about this recall.

    Distribution

    US Nationwide distribution.

    Quantity

    78 units