Device recall
Z-2106-2008: Artisan Control Catheter, model number 04454, manufactured by Hansen Medical…
FDA device recall · Class II · Hansen Medical Inc
Key facts
| Recall number (Z-number) | Z-2106-2008 |
|---|---|
| Recall event | 48444 |
| Product | Artisan Control Catheter, model number 04454, manufactured by Hansen Medical, Inc., Mountain View, CA. Steerable guide catheter for human use intended to facilitate manipulation, positioning and control for collecting electrophysiological data within the heart atria. |
| Product code | DRA |
| Recalling firm | Hansen Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 27, 2009 |
| 510(k) numbers | K052480 |
| FEI number | 3006026430 |
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