Device recall
Z-0660-2022: The Optima Coil System consists of an implantable embolization coil comprised of…
FDA device recall · Class II · BALT USA, LLC
Key facts
| Recall number (Z-number) | Z-0660-2022 |
|---|---|
| Recall event | 89338 |
| Product | The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher… |
| Product code | HCG |
| Recalling firm | BALT USA, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | 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