Device recall
Z-0497-2010: TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN…
FDA device recall · Class I · Ev3, Inc.
Key facts
| Recall number (Z-number) | Z-0497-2010 |
|---|---|
| Recall event | 53879 |
| Product | TrailBlazer Support Catheter, ev3 inc, 4600 Nathan Lane North, Plymouth, MN 55442-2920, Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, and SC-035-150. Intended to guide and support a guide wire during access of the… |
| Product code | DQY |
| Recalling firm | Ev3, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 5, 2011 |
| 510(k) numbers | K092299 |
| FEI number | 2183870 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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