Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Elana Surgical KitHUD The Elana Surgical KitHUD Recalled by Elana, Inc. Due to Elana has issued this Field Action to voluntarily...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Elana, Inc. directly.
Affected Products
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
Quantity: 4
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: NY
About Elana, Inc.
Elana, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report