Device recall
Z-0698-2017: Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the…
FDA device recall · Class II · Elana, Inc.
Key facts
| Recall number (Z-number) | Z-0698-2017 |
|---|---|
| Recall event | 75632 |
| Product | Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a… |
| Product code | PAX |
| Recalling firm | Elana, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 20, 2016 |
| FEI number | 3006784599 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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