Device recall
Z-2581-2010: Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation…
FDA device recall · Class II · Cardima Inc
Key facts
| Recall number (Z-number) | Z-2581-2010 |
|---|---|
| Recall event | 56046 |
| Product | Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA |
| Product code | OCL |
| Recalling firm | Cardima Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 23, 2011 |
| 510(k) numbers | K022008, K060715 |
| FEI number | 1000150772 |
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