Device recall
Z-1042-2024: The Prestige Coil System is a product family of embolic coils with associated…
FDA device recall · Class II · BALT USA, LLC
Key facts
| Recall number (Z-number) | Z-1042-2024 |
|---|---|
| Recall event | 93751 |
| Product | The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reducing flow into the… |
| Product code | KRD |
| Recalling firm | BALT USA, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K220699 |
| 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