NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part… recallZ-1393-2022 · Synapse Biomedical Inc · initiated May 31, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synapse Biomedical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Labeling design
What the company is doing
On May 31, 2022, the firm began to contact all affected customer sites. Customers were informed that the way the temperature storage conditions are stated on the labeling of these devices could lead to improper storage that, under certain circumstances, could damage the devices. Synapse will visit customer facilities to place a label with proper storage conditions over the current storage conditions on the device label. Customers who would rather not have a site visit may destroy their devices and Synapse will replace them. The firm will also provide a revised Surgeon Instruction Manual that includes a description of the storage temperature symbol.
Recall details
- Recall number
- Z-1393-2022
- Status
- Terminated
- Initiated by the company
- May 31, 2022
- Recalling firm
- Synapse Biomedical Inc
- Quantity
- 71
- Product code
- OIR
- 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.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
UDI-DI: 00852184003007 00852184003045 00852184003038 00852184003267 00852184003090 00852184003106 00852184003113 00852184003120 00852184003137 00852184003144 00852184003151 00852184003168 00852184003175 00852184003182 00852184003281 00852184003052 Lots/Serial Numbers: 20-0035-113021-3-3 20-0035-120221-2-1 20-0035-121621-5-2 20-0035-121621-5-3 20-0035-010722-5-4 20-0035-010722-5-5 20-0035-030722-2-2 20-0035-031122-5-1 20-0035-031122-5-2 20-0035-031122-5-5 20-0035-033122-5-1 20-0035-033122-5-2 20-0035-033122-5-3 20-0035-040622-4-1 20-0035-040622-4-2 20-0035-040622-4-3 20-0035-040622-4-2 20-0035-042122-1-1 20-0028-060221-5 20-0028-062421-5 20-0028-062521-5 20-0028-072821-5 20-0028-031022-5 20-0040-012221-10 20-0040-012221-10 20-0040-021921-9 20-0040-012221-10 20-0040-012221-10 20-0040-021921-9 20-0040-021921-9 20-0040-021921-9 20-0040-021921-9 20-0040-012621-10 20-0040-012621-10 20-0040-012621-10 20-0040-012621-10 20-0040-060221-5 20-0040-060221-5 20-0040-060221-5 20-0040-060221-5 20-0040-060221-5 20-0040-060821-5 20-0040-060821-5 20-0040-060821-5 20-0040-060821-5 20-0040-060821-5 20-0040-071321-6 20-0040-071321-6 20-0040-092021-10 20-0040-092021-10 20-0040-071521-2 20-0040-092021-10 20-0040-092021-10 20-0040-092021-10 20-0040-100721-10 20-0040-100721-10 20-0040-100721-10 20-0040-100721-10 20-040-100721-10 20-0040-100721-10 20-0040-100721-10 20-0040-122121-10 20-0040-122121-10 20-0040-122121-10 20-0040-122121-10 20-0040-010622-10 20-0040-121621-1 20-0040-020822-10 20-0040-010622-10 20-0040-040122-2
Devices named in this recall
8 devices in the FDA device registry whose identifier appears in the recall's code information.
- NeuRx Diaphragm Pacing System 20-0035Synapse Biomedical, Inc. · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator1 recall5 reports
- System Kit, ALS HDE 20-0045Synapse Biomedical, Inc. · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator1 recall1 death3 reports
- NeuRx DPS™ Surgical Kit, HDE 20-0028Synapse Biomedical, Inc. · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator1 recall0 reports
- STERILE Mapping Probe 21-0001-99Synapse Biomedical, Inc. · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator1 recall0 reports
- STERILE Lead Tunnelers 21-0007-99Synapse Biomedical, Inc. · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator1 recall0 reports
- STERILE Trocar to Transducer Tubing 21-0010-99Synapse Biomedical, Inc. · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator1 recall0 reports
- STERILE Touchproof Cable, Green 21-0023-99Synapse Biomedical, Inc. · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator1 recall0 reports
- STERILE Touchproof Cable Yellow 21-0025-99Synapse Biomedical, Inc. · Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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