Recall Z-1561-2022— Synapse Biomedical Inc
Class I · Terminated
Class I FDA medical device recall by Synapse Biomedical Inc, initiated 2022-07-11, terminated 2023-10-24. FDA's recall record names no specific 510(k) clearance for this event. Product: NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.. Reason: 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..
- Recalling firm
- Synapse Biomedical Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2022-07-11
- Terminated
- 2023-10-24
- Firm location
- Oberlin, OH, United States
Product description
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.