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
    26561
  • Event Risk Class
    Class 2
  • Event Number
    Z-1009-03
  • Event Initiated Date
    2003-06-23
  • Event Date Posted
    2003-07-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27895
  • 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
    Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
  • Action
    On June 23, 2003, sales representatives began retrieving any recalled pacemakers, which were not implanted. For implanted pacemakers, an 'Important Patient Management Information' letter, dated June 23, 2003, was sent to physicians recommending that pacemaker-dependent patients, with the potentially affected pacemakers, be scheduled for exams to check for proper pacemaker performance using a programmer.

Device

Device Recall Guidant
  • Model / Serial
    Serial numbers 110685, 110687, 110688, 110706, 110708, 110709, 110710, 110711, 110712, 110713 110714, and 110715
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide in the United States and worldwide.
  • Product Description
    Pulsar Max II Multiprogrammable Pacemaker, Model 1180
  • 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