Synapse Biomedical recalls NeuRx Diaphragm Pacing System External Pulse Generator Part 23-0021 due to potential breathing problems from device failure. Affected units have serial numbers 1900-2017.
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.
Synapse Biomedical is recalling a specific part of their NeuRx Diaphragm Pacing System that could cause breathing problems, pain, or cardiac arrest if it fails. This is a serious risk for people who use the device for medical breathing support.
The device's controller board has a defect that can cause it to stop working unexpectedly or malfunction over time. This might lead to breathing problems, pain, muscle fatigue, or even cardiac arrest in users who depend on the device for medical support.
People with a NeuRx Diaphragm Pacing System who own the external pulse generator with serial numbers 1900 through 2017 are affected. Those who rely on the device for breathing support are at the highest risk.
Check if your NeuRx Diaphragm Pacing System has an external pulse generator (EPG) with serial numbers 1900 through 2017. The part number is 23-0021.
Verify if your EPG has serial numbers 1900 through 2017 and part number 23-0021.
Reach out to Synapse Biomedical for guidance on next steps if you have the affected part.
Yes, the device could cause breathing problems, pain, muscle fatigue, or cardiac arrest if it fails.
Check if your EPG has serial numbers 1900 through 2017 and part number 23-0021. Contact Synapse Biomedical for next steps.
Look for serial numbers 1900 through 2017 on the external pulse generator (EPG) with part number 23-0021.
We’ve drafted a message you can send Synapse Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-1561-2022 — Synapse Biomedical Synapse Biomedical Hello, I own a Synapse Biomedical that is covered by recall Z-1561-2022 from Synapse Biomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
