Device recall
Z-2666-2011: LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-2666-2011 |
|---|---|
| Recall event | 58884 |
| Product | LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only. |
| Product code | DRF |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 12, 2012 |
| 510(k) numbers | K002333 |
| FEI number | 3003113629 |
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