Device recall
Z-0841-2012: Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL…
FDA device recall · Class III · Micro Therapeutics Inc, dba ev3 Neurovascular
Key facts
| Recall number (Z-number) | Z-0841-2012 |
|---|---|
| Recall event | 50776 |
| Product | Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held I.D. (instant detacher) which when activated detached the coil from the… |
| Product code | HCG |
| Recalling firm | Micro Therapeutics Inc, dba ev3 Neurovascular |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 26, 2012 |
| 510(k) numbers | K060747 |
| 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