Device recall
Z-2403-2021: EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA device recall · Class I · Micro Therapeutics Inc,
Key facts
| Recall number (Z-number) | Z-2403-2021 |
|---|---|
| Recall event | 88447 |
| Product | EV3 Pipeline Flex Embolization Device with Flex Shield Technology |
| Product code | OUT |
| Recalling firm | Micro Therapeutics Inc, |
| Recall class | Class I |
| Status | Open, Classified |
| 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