Device recall
Z-0307-2017: Pipeline Embolization Device (Pipeline Classic) The device is indicated for the…
FDA device recall · Class I · Micro Therapeutics Inc, Dba Ev3 Neurovascular
Key facts
| Recall number (Z-number) | Z-0307-2017 |
|---|---|
| Recall event | 75358 |
| Product | Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal segements. Catalog No… |
| Product code | OUT |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 11, 2017 |
| 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