Class I — Synapse Biomedical Inc
| Recalling firm | Synapse Biomedical Inc. |
|---|---|
| Registered facility | SYNAPSE BIOMEDICAL INC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| 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. |
| Product | NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021. |
| Quantity | 118 (112 US, 6 OUS) |
| Distribution | distribution to US states of AL, CO, IL, FL, GA, MD, MN, NC, NJ, OH, PA, and SC; Germany and Kuwait. ***Updated 3/28/23 - Product was not distributed to United Arab Emirates. Product was distributed to Kuwait.*** Updated 9.14.23 - 1 patient in Germany, 1 patient in the Czech Republic, 1 distributor in Kuwait |
| Initiated | 2022-07-11 |
| Classified | 2022-08-22 |
| Terminated | 2023-10-24 |
| Recall number | Z-1561-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Synapse Biomedical Inc (Z-1561-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90626/
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