Events

Recall of Device Recall Medtronic Atakr

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic,Inc/Rice Creek Facil.

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
    25111
  • Event Risk Class
    Class 2
  • Event Number
    Z-0618-03
  • Event Initiated Date
    2002-11-25
  • Event Date Posted
    2003-03-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25222
  • 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, Percutaneous - Product Code DQY
  • Reason
    An rf pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.
  • Action
    An "Important Product Management Information" letter dated November 25, 2002 was sent to the affected consignees (hospitals) and it recommended certain actions to avoid the problem and stated that a software revision, (version 1.36) had been developed to eliminate the problem.

Device

Device Recall Medtronic Atakr

Manufacturer

Medtronic,Inc/Rice Creek Facil
  • Manufacturer Address
    Medtronic,Inc/Rice Creek Facil, 7000 Central Ave N.E., Fridley MN 55432
  • Source
    USFDA