Device recall
Z-2664-2011: ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-2664-2011 |
|---|---|
| Recall event | 58884 |
| Product | ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT 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 | 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