Events

Recall of Device Recall Elana Catheter Sizer 2.0

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
    64538
  • Event Risk Class
    Class 2
  • Event Number
    Z-1143-2013
  • Event Initiated Date
    2013-02-14
  • Event Date Posted
    2013-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116430
  • 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
    Catheter, peripheral, atherectomy - Product Code MCW
  • Reason
    Distribution of an unapproved device into interstate commerce.
  • Action
    Elana Inc. issued an Urgent: Medical Device Recall letter on February 14, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the Elana Catheter Sizer 2.0 as soon as possible. The Sizer 2.0 was intended as an optional accessory to the Elana Surgical Kit. The Elana Surgical Kit may be used properly without the Elana Catheter Sizer 2.0. Please acknowledge receipt of these instructions immediately by Email: Claartje@elana.com or Fax: 301-215-7038. The return shipping address for the Sizer 2.0 is Elana, Inc., 10480 Little Patuxent Parkway, Suite 400, Columbia, MD 21044 USA. Contact information for questions: Phone: 301-215-7010 or 443-538-4923 or +1 31 30 2537276 www.elana.com.

Device

Device Recall Elana Catheter Sizer 2.0
  • Model / Serial
    Model 280, S/N 776, S/N 706, S/N 758
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of Pennsylvania, Texas, and New York.
  • Product Description
    Elana Catheter Sizer 2.0*** || The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.
  • Manufacturer
    Elana, Inc.

Manufacturer

Elana, Inc.
  • Manufacturer Address
    Elana, Inc., 10480 Little Patuxent Pkwy, Suite 400, Columbia MD 21044-3568
  • Source
    USFDA