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Recall Observatory FDA recall evidence

Device 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

Z-0698-2017

November 09, 2016

Class II

Product summary

Firm
Elana, Inc.
Event
Event 75632
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-0698-2017

Official wording

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.

Code information: Manufacturers Product Number, 801-H Lot/Serial Number, 160301

Distribution pattern: Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.