Device recall
Z-3037-2011: ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part…
FDA device recall · Class III · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-3037-2011 |
|---|---|
| Recall event | 59465 |
| Product | ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number D7R20P14CT The ISMUS Catheter with Auto ID Technology 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