Class 1 Device Recall INTELIS II pacemaker

• Date Initiated by Firm: July 18, 2005
• Date Posted: July 28, 2005
• Recall Status: Terminated on January 05, 2007
• Recall Number: Z-1038-05
• Recall Event ID: 32681
• PMA Number: P940031
• Product Classification: Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
• Product: INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . INTELIS 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. INTELIS II adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity.
• Code Information: Affected devices may be contained in the following serial number ranges. Model 1349: Serial numbers 100003 thru 100076. Model 1384: Serial numbers 300000 thru 300073. Model 1385: INITIAL RECALL serial numbers 400005 thru 400019. EXPANDED RECALL serial numbers 400003, 400004. Model 1483: Serial numbers 600005 thru 600082. Model 1484: Serial numbers 700005 thru 700064. Model 1485: INITIAL RECALL serial numbers 800005 thru 800053. EXPANDED RECALL serial numbers 800000, 800001, 800002, 800003, 800004. Model 1499: Serial numbers 200001 thru 200073.
• Recalling Firm/ Manufacturer: Guidant Corporation; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: INITIAL RECALL 228. EXPANDED RECALL 6.
• 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.
• 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.

• PMA Database: PMAs with Product Code = LWP and Original Applicant = BOSTON SCIENTIFIC