Events

Recall of Device Recall Flixene IFG with Assisted Delivery

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

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
    65697
  • Event Risk Class
    Class 2
  • Event Number
    Z-2307-2013
  • Event Initiated Date
    2013-07-12
  • Event Date Posted
    2013-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119918
  • 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
    Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
  • Reason
    Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field.
  • Action
    Atrium Medical Corporation issued an Urgent Medical Device Safety Alert letter on July 16, 2013, via UPS to customers and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. In addition, it provides instructions how to handle product that may be affected. For questions customers were instructed to contact their Atrium Medical Customer Service at 603-880-1433 Prompt 1 or by e-mail at returns@atriummed.com

Device

Device Recall Flixene IFG with Assisted Delivery
  • Model / Serial
    Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to the following countries: American Samoa Antilles Argentina Australia Austria Bangladesh Belgium Bolivia Brazil Canada Chile Colombia Egypt El Salvador Finland France Germany Great Britain Greece Guatemala Hong Kong India Indonesia Ireland Italy Jamaica Japan Korea Lebanon Libya Malaysia Mauritius Mexico Neal New Zealand Nicaragua Norway Pakistan Panama Peru Philippines Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore Slovenia South Africa Spain Switzerland Taiwan Thailand the Netherlands Trinidad Tunisia
  • Product Description
    Flixene IFG with Assisted Delivery || Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • Manufacturer Address
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    USFDA