Device recall
Z-1525-2015: WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of…
FDA device recall · Class II · Biosense Webster, Inc.
Key facts
| Recall number (Z-number) | Z-1525-2015 |
|---|---|
| Recall event | 71021 |
| Product | WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413 |
| Product code | DRF |
| Recalling firm | Biosense Webster, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2015 |
| 510(k) numbers | K892265 |
| 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