NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse… recallZ-1561-2022 · Synapse Biomedical Inc · initiated Jul 11, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synapse Biomedical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-1561-2022
- Status
- Terminated
- Initiated by the company
- Jul 11, 2022
- Posted by the FDA
- Aug 22, 2022
- Recalling firm
- Synapse Biomedical Inc
- Quantity
- 118 (112 US, 6 OUS)
- Product code
- OIR
- 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
Product description
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Code information (models, lots, serial numbers)
UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NeuRx DPS™ External Pulse Generator 23-0021Synapse Biomedical, Inc. · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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