Device recall
Z-0203-2024: Coapt Dome Electrode, Gen2 system, cutaneous electrode
FDA device recall · Class II · Coapt LLC
Key facts
| Recall number (Z-number) | Z-0203-2024 |
|---|---|
| Recall event | 93137 |
| Product | Coapt Dome Electrode, Gen2 system, cutaneous electrode |
| Product code | GXY |
| Recalling firm | Coapt LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190416 |
| FEI number | 3010605876 |
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