Device recall
Z-1703-2008: Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping…
FDA device recall · Class II · Biosense Webster Inc
Key facts
| Recall number (Z-number) | Z-1703-2008 |
|---|---|
| Recall event | 47522 |
| Product | Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e., recording and stimulation only. The device is designed to obtain electrograms in the… |
| Product code | DRF |
| Recalling firm | Biosense Webster Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 3, 2012 |
| 510(k) numbers | K031161 |
| FEI number | 3002951223 |
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