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
Enforcement
- Recall Number
- Z-0698-2017
- Event ID
- 75632
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Elana, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- December 14, 2016
- Initiation Date
- November 9, 2016
- Classification Date
- December 2, 2016
- Termination Date
- December 20, 2016
- Address
- 10480 Little Patuxent Pkwy Ste 400, N/A, Columbia, MD, 21044-3576, United States
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
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.
Manufacturers Product Number, 801-H Lot/Serial Number, 160301
Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
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