Device recall
Z-2045-2013: Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated…
FDA device recall · Class II · Micro Therapeutics Inc, Dba Ev3 Neurovascular
Key facts
| Recall number (Z-number) | Z-2045-2013 |
|---|---|
| Recall event | 65810 |
| Product | Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. |
| Product code | OUT |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 17, 2013 |
| PMA numbers | P100018 |
| FEI number | 3004904811 |
At a glance
- None 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