# FDA recall Z-1393-2022

> **Synapse Biomedical Inc** · Class III · device recall initiated 2022-05-31.

## Product

NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers:    Part #	             Part Name  20-0035	      NeuRx DPS System Kit  20-0036	      NeuRx Diaphragm Pacing System, Patient Kit, SCI  20-0028	      NeuRx DPS Surgical Kit, HDE  20-0040	      NeuRx Diaphragm Pacing System Spare Sterile Components  21-0001-99	Mapping Probe  21-0004-99	Indifferent Electrode  21-0007-99	Lead Tunneler Set  21-0009-99	Blue Cable Set  21-0010-99	Transducer Tubing  21-0017-99	PermaLoc Electrode  21-0023-99	Green Cable  21-0024-99	Orange Cable  21-0025-99	Yellow Cable  21-0026-99	White Cable  77-0050	      Surgeon Instruction Manual  20-0045       	NeuRx DPS System Kit, ALS HDE  20-0046	      NeuRx Diaphragm Pacing System, Patient Kit, ALS      Marketed under HDE H070003 as well as H100006

## Reason for recall

Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

## Distribution

Domestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX WV.  Foreign distribution pending.

## Key facts

- **Recall number:** Z-1393-2022
- **Recalling firm:** Synapse Biomedical Inc
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-05-31
- **Report date:** 2022-07-27
- **Termination date:** 2024-04-11

- **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-1393-2022

## Citation

> AI Analytics. FDA recall Z-1393-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1393-2022. Source: US FDA. Licensed CC0.

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