Device recall
Z-1108-06: X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US…
FDA device recall · Class III · Ev3, Inc
Key facts
| Recall number (Z-number) | Z-1108-06 |
|---|---|
| Recall event | 34708 |
| Product | X-Sizer Thrombectomy Catheter System (ev3) Model number XD-CS1200-55 (for US distribution). Model number XR-CS1200-55 (for foreign distribution). 2.0mm. Sterilization with Ethylene Oxide Gas. ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. |
| Product code | MCW |
| Recalling firm | Ev3, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 26, 2006 |
| 510(k) numbers | K021096 |
| FEI number | 2183870 |
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