Device recall
Z-3038-2011: Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S…
FDA device recall · Class III · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-3038-2011 |
|---|---|
| Recall event | 59465 |
| Product | Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT Duo-Decapolar Electrophysiology Catheter has been designed for electrophysiological mapping of cardiac structures. |
| Product code | DRF |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 12, 2012 |
| 510(k) numbers | K953768 |
| 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