Events

Recall of Device Recall Guidant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Guidant Corp-Cpi Division.

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
    26235
  • Event Risk Class
    Class 2
  • Event Number
    Z-0878-03
  • Event Initiated Date
    2003-05-06
  • Event Date Posted
    2003-05-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27332
  • 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
    Implantable Pacemaker Pulse-Generator - Product Code DXY
  • Reason
    In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
  • Action
    An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.

Device

Device Recall Guidant
  • Model / Serial
    All Serial numbers
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide in the United States and worldwide.
  • Product Description
    Contak TR Multiprogrammable Pacemaker, DDDR Model 1241
  • Manufacturer
    Guidant Corp-Cpi Division

Manufacturer

Guidant Corp-Cpi Division
  • Manufacturer Address
    Guidant Corp-Cpi Division, 4100 N Hamline Ave, St Paul MN 55112-5798
  • Source
    USFDA