Diaphragm pacing system external pulse generator recalled for circuit board defect
Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4. While the source does not report actual illnesses or deaths, the potential adverse events (cardiac arrest, decreased breathing effectiveness) combined with the FDA Class I designation justify a Severe rating.
Plain-English summary
Synapse Biomedical Inc is recalling the NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator, Part No. 23-0021 (serial numbers 1900–2017). The recall affects 118 units distributed to patients in the United States (Alabama, Colorado, Illinois, Florida, Georgia, Maryland, Minnesota, North Carolina, New Jersey, Ohio, Pennsylvania, and South Carolina), Germany, the Czech Republic, and a distributor in Kuwait.
The recall was initiated due to a defect identified in the EPG controller printed circuit board assembly. This defect may cause the device's performance to degrade over time, potentially resulting in serious adverse events. Depending on the nature of the device failure, potential adverse events include cardiac arrhythmia, cardiac arrest, decreased breathing effectiveness, muscle fatigue, pain, or unexpected device shutdown.
The recalled product
- Product
- NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
- Manufacturer
- Synapse Biomedical Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00852184003212
- Serial Nos. 1900 thru 2017
Distribution
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