FDA Device recall Z-1561-2022
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021
- FDA Device
- Class I
- terminated
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class I recall of NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021 by Synapse Biomedical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1561-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-07-11 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Synapse Biomedical |
| Distribution | AL, CO, FL, GA, IL, MD, MN, NC, NJ, OH, PA, SC |
Product
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.
Identifiers
| code_info | UDI-DI: 00852184003212; Serial Nos. 1900 thru 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1561-2022%22
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