Recall Z-0698-2017— Elana, Inc.
Class II · Terminated
Class II FDA medical device recall by Elana, Inc., initiated 2016-11-09, terminated 2016-12-20. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- Elana, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-09
- Terminated
- 2016-12-20
- Firm location
- Columbia, MD, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.