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U.S. Department of Health and Human Services

Class 2 Device Recall INSIGNIA Entra and NEXUS Entra

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  Class 2 Device Recall INSIGNIA Entra and NEXUS Entra see related information
Date Initiated by Firm September 22, 2005
Date Posted November 23, 2005
Recall Status1 Terminated 3 on January 05, 2007
Recall Number Z-0191-06
Recall Event ID 33871
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
Product 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.
Code Information All serial numbers.
Recalling Firm/
Guidant Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5798
Manufacturer Reason
for Recall
Another failure mode, which occurs at a low rate, has been identified with 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.
FDA Determined
Cause 2
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. UPDATE: Guidant is issuing an Advisory Update to physicians in December 2005. This update provides information relative to the failure mode including the identified cause; FDA's classification; Guidant representatives will retrieve and replace any hospital inventory with product free from "Mode 2" peri-implant failure; and recommended actions.
Quantity in Commerce 93,896
Distribution Nationwide and Arab Emerites, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Peru, Philippines, Polynesia, Portugal, Qatar, Reunion, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan ROC, Thailand, Turkey, United Kingdom, Urguay and Venezuela
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.