BEUDAMED
    FDA Enforcement Class I Terminated

    NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.

    Recall: Z-1561-2022 · Reported August 31, 2022

    Enforcement

    Recall Number
    Z-1561-2022
    Event ID
    90626
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synapse Biomedical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 31, 2022
    Initiation Date
    July 11, 2022
    Classification Date
    August 22, 2022
    Termination Date
    October 24, 2023
    Address
    300 Artino St, Oberlin, OH, 44074-1263, United States

    Description

    NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.

    Reason

    Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or the device may stop unexpectedly.

    Code Info

    UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017

    Distribution

    distribution to US states of AL, CO, IL, FL, GA, MD, MN, NC, NJ, OH, PA, and SC; Germany and Kuwait. ***Updated 3/28/23 - Product was not distributed to United Arab Emirates. Product was distributed to Kuwait.*** Updated 9.14.23 - 1 patient in Germany, 1 patient in the Czech Republic, 1 distributor in Kuwait

    Quantity

    118 (112 US, 6 OUS)