Class 2 Device Recall INSIGNIA Ultra and NEXUS Ultra

• Date Initiated by Firm: September 22, 2005
• Date Posted: September 24, 2005
• Recall Status: Terminated on December 27, 2006
• Recall Number: Z-0188-06
• Recall Event ID: 33491
• Product Classification: Implantable Pacemaker Pulse-Generator - Product Code DXY
• Product: Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra 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. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. 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: INSIGNIA Ultra SR (model 1190) serial no. 889963 - 891468; NEXUS Ultra SR (model 1390) serial no. 100007 - 100034. INSIGNIA Ultra DR (model 1290) serial no. 100678 - 105229; (model 1291) serial no. 100279 - 100913; NEXUS Ultra DR (model 1490) serial no. 100007, 100008, 100009, 100013, 100014, 100015, 100016, 100017, 100018; (model 1491) serial no. 100007, 100008, 100009, 100010, 100013, 100015, 100016, 100017, 100018.
• Recalling Firm/ Manufacturer: Guidant Corporation; 4100 Hamline Ave N; Saint Paul MN 55112-5798
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 1281
• 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
• 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.