Events

Recall of Implantable Cardioverter Defibrilators || Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) || Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/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
    32465
  • Event Risk Class
    Class 2
  • Event Number
    Z-1017-05
  • Event Initiated Date
    2005-06-17
  • Event Date Posted
    2005-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40137
  • 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
    Two corrections to firmware due to skipped-charge shock and sensor noise anomaly are being made with one noninvasive upgrade.
  • Action
    Recall was by letter to Physicians sent by FEDEX. Follow-up upgrade to programmers will be done by firm representatives to the new version 4.8.5.

Device

Implantable Cardioverter Defibrilators || Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-2...
  • Model / Serial
    No serial numbers were given. All models mentioned are affected.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Sweden, Canada, Australia, New Zealand. South America and Asia
  • Product Description
    Implantable Cardioverter Defibrilators || Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF (V-236/V-239/V-196/V-239T/V-196T/V-350) || Atlas DR (V242), and Atlas Plus DR/VR/HF (V-243/V-193C/V-340/V-341/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