BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1561-2022 · Initiated July 11, 2022

    Recall

    Recall Number
    Z-1561-2022
    Event Number
    90626
    Firm
    Synapse Biomedical Inc
    FEI Number
    3005868392
    Product Code
    OIR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 11, 2022
    Posted
    August 22, 2022
    Terminated
    October 24, 2023
    Address
    300 Artino St, Oberlin, OH, 44074-1263

    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.

    Action

    On July 11, 2022, Synapse began contacting affected clinical sites where the devices were sent. An initial phone call was made to clinicians that have affected devices at their site or have patients with affected devices. A follow-up email is being sent each of the clinicians that includes a fact sheet for them about the recall, a fact sheet for patients that clinicians can forward to the patients and information about the specific EPGs that have been sent to their site. Patients are asked to register their devices at a webpage specifically developed for the purpose. Replacement devices are available from the manufacturer and arrangements are being made with clinicians and patients to have the devices programmed and delivered to patients as soon as possible. The manufacturer is asking that all devices be returned to Synapse Biomedical for disposal to ensure that no affected devices are inadvertently used at a later time.

    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)