Device recall
Z-3022-2018: ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL…
FDA device recall · Class II · Micro Therapeutics Inc, Dba Ev3 Neurovascular
Key facts
| Recall number (Z-number) | Z-3022-2018 |
|---|---|
| Recall event | 80831 |
| Product | ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use. |
| Product code | MCW |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 4, 2020 |
| 510(k) numbers | K111723 |
| FEI number | 3004904811 |
At a glance
- 1–9 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