Device recall
Z-1041-2024: Neurovascular embolization device. The Optima Coil System is a series…
FDA device recall · Class II · BALT USA, LLC
Key facts
| Recall number (Z-number) | Z-1041-2024 |
|---|---|
| Recall event | 93751 |
| Product | Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of… |
| Product code | HCG |
| Recalling firm | BALT USA, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K172390, K200030, K223386 |
| 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