Events

Recall of Device Recall DISCOVERY II pacemaker

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

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
    32681
  • Event Risk Class
    Class 1
  • Event Number
    Z-1036-05
  • Event Initiated Date
    2005-07-18
  • Event Date Posted
    2005-07-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40552
  • 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 Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
  • Reason
    A hermetic sealing component utilized in the device may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemeaker case late in the device's service life.
  • Action
    INITIAL RECALL Urgent medical Device Safety Information & Corrective Action letter dated 07/18/05 was issued to physicians listing clinical Implications and patient management recommendations. EXPANDED RECALL Press was issued January 23, 2006. Urgent Medical Device Safety Information & Corrective Action letter, dated 01/21/06, was issued to physicians listing a summary of previous communication to physicians, advisory population update, and information relative to a second population of devices manufactured between October 19, 1998 and December 5, 2000. This letter gives the observed rate of occurrence, clinical implications, projected rate of occurrence and recommendations.

Device

Device Recall DISCOVERY II pacemaker
  • Model / Serial
    Affected devices may be contained in the following serial number ranges.  Model 481: INITIAL RECALL serial numbers 100000 thru 100115. EXPANDED RECALL serial numbers 100185, 100213, 100356, 100357, 100360. Model 981: INITIAL RECALL serial numbers 200002 thru 200041. EXPANDED RECALL serial numbers 200145, 200150, 200178, 200192, 200312. Model 1184: INITIAL RECALL serial numbers 300012 thru 300061. EXPANDED RECALL serial numbers 300159 thru 301072 and 610018 thru 610035. Model 1186: INITIAL RECALL serial numbers 500000 thru 500054. EXPANDED RECALL serial numbers 500056 thru 500444 Model 1187: INITIAL RECALL serial numbers 450000 thru 450010. EXPANDED RECALL serial numbers 450027 thru 450056. Model 1283: INITIAL RECALL serial numbers 600001 thru 600073. EXPANDED RECALL serial numbers 600214 thru 602143 Model 1284: INITIAL RECALL serial numbers 700000 thru 700079. EXPANDED RECALL serial numbers 700296, 700343, 700452, 700506, 700552, 700561, 700566. Model 1286: INITIAL RECALL serial numbers 900000 thru 900059. EXPANDED RECALL serial numbers 900045 thru 900888.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cyprus, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guyana, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Singapore,Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan ROC, Turkey, United Kingdom, Uruguay and Venezuela. EXPANDED RECALL additional countries include: China, Croatia, Korea. Lithuania, Madagascar, Maldives, Malta, Monaco, Nepal and Thailand.
  • Product Description
    DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . DISCOVERY II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering both adaptive-rate therapy and conventional pacing therapy. These pacemakers provide various levels of therapeutic and diagnostic functionality. DISCOVERY II adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Manufacturer Address
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA