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U.S. Department of Health and Human Services

Class 2 Device Recall Elana Surgical KitHUD

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 Class 2 Device Recall Elana Surgical KitHUDsee related information
Date Initiated by FirmNovember 09, 2016
Create DateDecember 02, 2016
Recall Status1 Terminated 3 on December 20, 2016
Recall NumberZ-0698-2017
Recall Event ID 75632
Product Classification Surgical Kit - Product Code PAX
ProductElana 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
Code Information Manufacturers Product Number, 801-H  Lot/Serial Number, 160301 
FEI Number 3006784599
Recalling Firm/
Manufacturer		 Elana, Inc.
10480 Little Patuxent Pkwy Ste 400
Columbia MD 21044-3576
Manufacturer 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.
FDA Determined
Cause 2		Packaging
ActionElana sent an Urgent Medical Device Recall letter dated November 7, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected device and to return the product for replacement. Customers were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return and exchange. Customers with questions were instructed to call 301-215-7010.
Quantity in Commerce4
DistributionWorldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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