Device recall
Z-0120-2016: -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline…
FDA device recall · Class II · Micro Therapeutics Inc, Dba Ev3 Neurovascular
Key facts
| Recall number (Z-number) | Z-0120-2016 |
|---|---|
| Recall event | 72165 |
| Product | -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder… |
| Product code | OUT |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 18, 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