Z-0698-2017Class II

Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser...

Name: Z-0698-2017 Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser...
Creator: Elana, Inc.
Published: 2016-11-09
License: https://open.fda.gov/license/

Elana, Inc. / initiated 2016-11-09 / Terminated / root cause: packaging

FDA source

Elana, Inc. began a recall of Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating... on 2016-11-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0698-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-09
Posted: 2016-12-02
Terminated: 2016-12-20
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
Product code: PAX Surgical Kit
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.
Root cause tag: packaging
FDA 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 in commerce: 4
Distribution: Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
Product codes and lots: Manufacturers Product Number, 801-H Lot/Serial Number, 160301

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0698-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0698-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-02

Product code PAX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)