Events

Recall of Device Recall Uroglogix Targis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Urologix, 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
    37638
  • Event Risk Class
    Class 2
  • Event Number
    Z-0721-2007
  • Event Initiated Date
    2007-03-16
  • Event Date Posted
    2007-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51251
  • 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
    Microwave Delivery System - Product Code MEQ
  • Reason
    The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
  • Action
    A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.

Device

Device Recall Uroglogix Targis
  • Model / Serial
    Individual catheter lot number KG001346 for model TA1321D. Kit box lot number KGP111105.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide and the Netherlands.
  • Product Description
    Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D.
  • Manufacturer
    Urologix, Inc.

Manufacturer

Urologix, Inc.
  • Manufacturer Address
    Urologix, Inc., 14405 21st Ave N, Minneapolis MN 55447-4685
  • Source
    USFDA