Events

Recall of Device Recall Catheter, Introducer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Endologix 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
    65248
  • Event Risk Class
    Class 1
  • Event Number
    Z-1436-2013
  • Event Initiated Date
    2013-05-13
  • Event Date Posted
    2013-06-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118366
  • 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
    Introducer, catheter - Product Code DYB
  • Reason
    Endologix, inc. initiated this voluntary recall of certain lots of endologix, inc. due to reports of dilator breakage during clinical procedures.
  • Action
    Endologix Inc sent an "URGENT-MEDICAL DEVICE RECALL NOTICE" letters dated May 13, 2013 to all affected customers. The letter identified the affected product, reason for recall, and actions to be taken. The letter instructed customers to do not use or further distribute any affected product. The letter instructed customers to share this information with physicians that perform these procedures at the facility. The firm will call to confirm that this device is located at the facility. After confirmation the firm will retrieve the device. For questions call (800) 983-2284.

Device

Device Recall Catheter, Introducer
  • Model / Serial
    Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
  • Product Description
    Brand Name: AFX" Introducer System, Model Number S17-45. || Lot Numbers: 1079840, 1079843, 1079844, 1079845. || Product Usage: || The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
  • Manufacturer
    Endologix Inc

Manufacturer

Endologix Inc
  • Manufacturer Address
    Endologix Inc, 11 Studebaker, Irvine CA 92618-2013
  • Source
    USFDA