NeuRx Diaphragm Pacing System — Class I medical device recall Z-1561-2022
Terminated recall by Synapse Biomedical Inc, reported 2022-08-31, distributed in AL, CO, FL, GA, IL, MD, MN, NC…. Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrad
| Recall number | Z-1561-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synapse Biomedical Inc, Oberlin, OH, United States |
| Recall initiated | 2022-07-11 |
| Classified | 2022-08-22 |
| Reported by FDA | 2022-08-31 |
| Terminated | 2023-10-24 |
| Distributed | AL, CO, FL, GA, IL, MD, MN, NC, NJ, OH, PA, SC |
| Countries outside the US | AE, CZ, DE, KW |
| UPC / GTIN / UDI-DI | 00852184003212 |
| Serial numbers | 1900 |
| Model numbers | 23-0021 |
Product
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1561-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.