Device recall
Z-0873-2012: Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System…
FDA device recall · Class III · Micro Therapeutics Inc, dba ev3 Neurovascular
Key facts
| Recall number (Z-number) | Z-0873-2012 |
|---|---|
| Recall event | 55696 |
| Product | Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. |
| Product code | HCG |
| Recalling firm | Micro Therapeutics Inc, dba ev3 Neurovascular |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 31, 2012 |
| 510(k) numbers | K060747, K081465 |
| 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