Events

Recall of Device Recall Elana Surgical KitHUD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Elana, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75632
  • Event Risk Class
    Class 2
  • Event Number
    Z-0698-2017
  • Event Initiated Date
    2016-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150965
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Surgical Kit - Product Code PAX
  • 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.
  • 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.

Device

Device Recall Elana Surgical KitHUD
  • Model / Serial
    Manufacturers Product Number, 801-H  Lot/Serial Number, 160301
  • Product Classification
    Neurological Devices
  • Device Class
    HDE
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
  • 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
  • Manufacturer
    Elana, Inc.

Manufacturer

Elana, Inc.
  • Manufacturer Address
    Elana, Inc., 10480 Little Patuxent Pkwy Ste 400, Columbia MD 21044-3576
  • Source
    USFDA