FDANovember 9, 2016device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
elana
Recall history
No related federal recalls on record for this brand yet.
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