Device recall
Z-0103-2023: Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used…
FDA device recall · Class II · BALT USA, LLC
Key facts
| Recall number (Z-number) | Z-0103-2023 |
|---|---|
| Recall event | 90870 |
| Product | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures. |
| Product code | HCG |
| Recalling firm | BALT USA, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172390, K200030 |
| FEI number | 3014162263 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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