Z-1561-2022Class I

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

Name: Z-1561-2022 NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021
Creator: Synapse Biomedical Inc
Published: 2022-07-11
License: https://open.fda.gov/license/

Synapse Biomedical Inc / initiated 2022-07-11 / Terminated / root cause: manufacturing process

FDA source

Synapse Biomedical Inc began a recall of NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021 on 2022-07-11. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1561-2022
Classification: Class I
Status: Terminated
Initiated: 2022-07-11
Posted: 2022-08-22
Terminated: 2023-10-24
Recalling firm: Synapse Biomedical Inc
Product: NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Product code: OIR Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 118 (112 US, 6 OUS)
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 codes and lots: UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1561-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1561-2022	Class I	Terminated	Voluntary: Firm initiated	2022-08-31	2022-08-22

Product code OIR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)