Device recall
Z-1647-2012: EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-1647-2012 |
|---|---|
| Recall event | 48179 |
| Product | EZ STEER Catheter D-1267-04-S / 8mm Non-Navigation Bi-Directional Catheter Cardiovascular catheter for use in electrophysiological diagnosis and ablation. |
| Product code | DRF |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2012 |
| 510(k) numbers | K090898, K101345 |
| 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