NeuRx Diaphragm Pacing System Labeling Revised for Storage Clarity
Synapse Biomedical revised labeling for the NeuRx Diaphragm Pacing System to clarify that temperature range symbols indicate storage conditions, not transport or package conditions. The revision affects 71 units distributed in the United States.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall involving labeling clarification for proper storage conditions, with no reported injuries or adverse events. The issue is documentation-related, falling under cosmetic and documentation problems per the severity rubric.
Plain-English summary
The NeuRx Diaphragm Pacing System (NeuRx DPS), manufactured by Synapse Biomedical Inc, is a medical device system used for diaphragm pacing to assist breathing in patients with spinal cord injury or ALS.
The manufacturer has revised the device labeling to consistently identify and describe storage conditions. The instructions for use have been clarified to explicitly state that temperature range symbols on the device indicate storage conditions only, and do not refer to transport conditions or tolerance conditions for the package material. This clarification was necessary to prevent confusion about proper device storage.
This revision affects 71 units of the NeuRx DPS system and related components. Affected devices have been distributed domestically to healthcare facilities in Alabama, California, Colorado, Florida, Georgia, Illinois, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, and West Virginia.
Patients and healthcare providers using affected units should review the updated device labeling and instructions for use to ensure the device is stored according to the specified temperature range.
The recalled product
- 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…
- Manufacturer
- Synapse Biomedical Inc
- Hazard
- Affected units
- 71
Distribution
Related recalls
Same manufacturer · Synapse Biomedical Inc
See all →- SevereDiaphragm pacing system external pulse generator recalled for circuit board defect
FDA (Devices) · 2022-08-31
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- SevereDiaphragm pacing system external pulse generator recalled for circuit board defect
FDA (Devices) · 2022-08-31
- ModerateFDA Recalls Composix L/P Mesh Due to Labeling Mismatch
FDA (Devices) · 2014-01-29
- ModerateInspire Respiratory Sensing Lead Model 4340 Serial Number Label Mismatch
FDA (Devices) · 2024-10-16
- ModerateCook Medical Recalls Nephrostomy Balloon Sets Due to Labeling Mix-up
FDA (Devices) · 2016-03-30
- ModerateMedtronic Recalls DLP Pressure Display Sets Due to Packaging Pinholes
FDA (Devices) · 2017-08-02
- HighBoston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error
FDA (Devices) · 2013-07-17