Device recall
Z-1393-2022: NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part…
FDA device recall · Class III · Synapse Biomedical Inc
Key facts
| Recall number (Z-number) | Z-1393-2022 |
|---|---|
| Recall event | 90386 |
| Product | NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe… |
| Product code | OIR |
| Recalling firm | Synapse Biomedical Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 11, 2024 |
| FEI number | 3005868392 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database