Z-0698-2017 Class II Terminated
FDA device recall Z-0698-2017 was initiated by Elana, Inc. on November 9, 2016 and is designated Class II. 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 Cathe… The recall status is terminated (terminated December 20, 2016). Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2016
- Initiation Date
- November 9, 2016
- Termination Date
- December 20, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
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
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.
Distribution Pattern
Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
Code Information
Manufacturers Product Number, 801-H Lot/Serial Number, 160301