Events

Recall of Implantable Cardioverter-Defibrillator || Models affected include the following: || Atlas+ Models V-193, V-193C and V-243 || Epic+ Models V-196, V-236 and V-239 || Epic Models V-197 and V-233 || Atlas Model V-242 || Epic HF Models V-337 and V-338 || Epic+HF Models V-339 and V-350 || Atlas+ HF Models V-340, V-341 and V-343

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

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
    31515
  • Event Risk Class
    Class 2
  • Event Number
    Z-0709-05
  • Event Initiated Date
    2005-03-10
  • Event Date Posted
    2005-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38035
  • 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
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
  • Reason
    Sensitivity of a magnetic switch was not being set correctly. this could result in delivery of an unneeded shock during surgery with use of electrocautery.
  • Action
    Notification materials were distributed to sales representatives on March 10, 2005. They will visit each doctor that is following the devices.

Device

Implantable Cardioverter-Defibrillator || Models affected include the following: || Atlas+ Models...
  • Model / Serial
    Too numerous to include here.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Canada, Australia, Sweden, Brazil, Colombia, Argentina.
  • Product Description
    Implantable Cardioverter-Defibrillator || Models affected include the following: || Atlas+ Models V-193, V-193C and V-243 || Epic+ Models V-196, V-236 and V-239 || Epic Models V-197 and V-233 || Atlas Model V-242 || Epic HF Models V-337 and V-338 || Epic+HF Models V-339 and V-350 || Atlas+ HF Models V-340, V-341 and V-343
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Manufacturer Address
    St Jude Medical, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA