Reported Aug 31, 2022 · Terminated
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
Synapse Biomedical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synapse Biomedical Inc · 300 Artino St · Oberlin, OH · 44074-1263
Is this the product you have?
- NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
- Lot codes and dates
- UDI-DI
00852184003212Serial Nos. 1900 thru 2017
- UDI-DI
- Amount recalled
- 118 (112 US, 6 OUS)
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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