FDA Device recall Z-0698-2017
Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for c…
- FDA Device
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for c… by Elana, citing elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to potentially compromised integrity of the outer sterile packagi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0698-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-09 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Elana |
| Distribution | NY |
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 large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity
Reason
Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to potentially compromised integrity of the outer sterile packaging of the Elana Catheter 2.0.
Identifiers
| code_info | Manufacturers Product Number, 801-H Lot/Serial Number, 160301 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0698-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.