Device recall
Z-0470-2019: BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2…
FDA device recall · Class I · Synaptive Medical Inc
Key facts
| Recall number (Z-number) | Z-0470-2019 |
|---|---|
| Recall event | 81317 |
| Product | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath… |
| Product code | HAW |
| Recalling firm | Synaptive Medical Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 12, 2021 |
| 510(k) numbers | K153281 |
| FEI number | 3012075008 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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