Device recall
Z-3326-2026: Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI…
FDA device recall · Class II · Micro Therapeutics, Inc.
Key facts
| Recall number (Z-number) | Z-3326-2026 |
|---|---|
| Recall event | 99689 |
| Product | Pipeline Flex Embolization Device with Shield Technology REF PED2-300-12 UDI-DI code: 00763000448806 he Pipeline Flex Embolization Device with Shield Technology consists of a permanent implant combined with a guidewire based delivery system. The Pipeline Flex Embolization Device with Shield… |
| Product code | OUT |
| Recalling firm | Micro Therapeutics, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| PMA numbers | P100018, P100018S026 |
| FEI number | 1000220862 |
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