Device recall
Z-0653-2017: COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA…
FDA device recall · Class II · AtriCure, Inc.
Key facts
| Recall number (Z-number) | Z-0653-2017 |
|---|---|
| Recall event | 75373 |
| Product | COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the… |
| Product code | OCL |
| Recalling firm | AtriCure, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 8, 2018 |
| 510(k) numbers | K113475 |
| FEI number | 3011706110 |
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