# FDA recall Z-1561-2022

> **Synapse Biomedical Inc** · Class I · device recall initiated 2022-07-11.

## 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.

## 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

## Key facts

- **Recall number:** Z-1561-2022
- **Recalling firm:** Synapse Biomedical Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-07-11
- **Report date:** 2022-08-31
- **Termination date:** 2023-10-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oberlin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2022

## Citation

> AI Analytics. FDA recall Z-1561-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1561-2022. Source: US FDA. Licensed CC0.

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