Class 1 Device Recall DISCOVERY II pacemaker

• Date Initiated by Firm: July 18, 2005
• Date Posted: July 28, 2005
• Recall Status: Terminated on January 05, 2007
• Recall Number: Z-1036-05
• Recall Event ID: 32681
• PMA Number: P940031
• Product Classification: Implantable Pulse Generator, Pacemaker (Non-Crt) - Product Code LWP
• Product: 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.
• Code Information: 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.
• 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 414. EXPANDED RECALL 2,367
• 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