Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG) Recalled by Synapse Biomedical Inc Due to Due to a defect identified on the EPG...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synapse Biomedical Inc directly.
Affected Products
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Quantity: 118 (112 US, 6 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 12 states: AL, CO, FL, GA, IL, MD, MN, NJ, NC, OH, PA, SC
About Synapse Biomedical Inc
Synapse Biomedical Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report