FDA Medical Device Recalls (openFDA)
Elana, Inc.: 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
- Recall number
- Z-0698-2017
- Recalling firm
- Elana, Inc.
- 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
- Status
- Terminated
- Initiated
- 2016-11-09
- Posted
- not on file
- Terminated
- 2016-12-20
- 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.
- Root cause
- Packaging
- Action
- Elana 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
- 4
- Distribution
- Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
- Lot, serial or model codes
- Manufacturers Product Number, 801-H Lot/Serial Number, 160301
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PAX
- Firm FEI
- 3006784599
- Firm city
- Columbia
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28