Elana Surgical KitHUD The Elana Surgical KitHUD — Class II medical device recall Z-0698-2017
Terminated recall by Elana, Inc., reported 2016-12-14, distributed in NY. Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD
| Recall number | Z-0698-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elana, Inc., Columbia, MD, United States |
| Recall initiated | 2016-11-09 |
| Classified | 2016-12-02 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2016-12-20 |
| Distributed | NY |
| Countries outside the US | CH, NL |
| Quantity | 4 |
| Reason classes | sterility |
| Serial numbers | 160301 |
| Model numbers | CVX-300 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0698-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.