Elana, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0698-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 9, 2016

Date Posted: December 14, 2016

Recall Number: Z-0698-2017

Event ID: 75632

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.

Status: Terminated

Product Quantity: 4

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.

Voluntary or Mandated:

Voluntary: Firm initiated