Events

Recall of INSIGNIA Entra and NEXUS Entra

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
    33491
  • Event Risk Class
    Class 2
  • Event Number
    Z-0187-06
  • Event Initiated Date
    2005-09-22
  • Event Date Posted
    2005-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41956
  • 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
    A failure mode occurring at a low rate, has been identified within the insignia and nexus families of implantable pacemakers. device behaviors which may be observed include: intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.
  • Action
    Important Medical Device Safety Information & Corrective Action , dated 09/22/05 was sent to all affected physicians. This letter explained the failure mode, what devices are affected and gave recommendations. A press release was issued on 09/22/05.

Device

INSIGNIA Entra and NEXUS Entra
  • Model / Serial
    Affected devices may be found in the following serial number ranges. INSIGNIA Entra SSI (model 0484) serial no. 100879 - 115237; (model 0485) serial no. 100088 - 100104; NEXUS Entra SSI (model 1326) serial no. 100122 - 100175. INSIGNIA Entra DDD (model 0985) serial no. 100059 - 100089; (model 0986) serial no. 100600 - 104439; NEXUS Entra DDD (model 1426) serial no. 100032 - 100091. INSIGNIA Entra SR (model 1195) serial no. 100739 - 101623; (model 1198) serial no. 102498 - 117468; NEXUS Entra SR (model 1398) serial no. 100067 - 100120. INSIGNIA Entra DR (model 1294) serial no. 101132 - 107445 & 292190; (model 1295) serial no. 100503 - 102668; (model 1296) serial no. 101519 - 153064; NEXUS Entra DR (model 1494) serial no. 100028 & 100029.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide and Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Polynesia, Portugal, Qatar, Reunion, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Venezuela
  • Product Description
    Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Manufacturer Address
    Guidant Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5798
  • Source
    USFDA