Class 2 Device Recall Guidant

• Date Initiated by Firm: June 23, 2003
• Date Posted: July 15, 2003
• Recall Status: Terminated on July 02, 2004
• Recall Number: Z-1012-03
• Recall Event ID: 26561
• Product Classification: Implantable Pacemaker Pulse-Generator - Product Code DXY
• Product: Discovery II Multiprogrammable Pacemaker, Model 0981
• Code Information: Serial numbers 206555, 206557, 206558, 206559, 206560, 206561, 206562, 206525, 206526, 206527, 206528, and 206529
• Recalling Firm/ Manufacturer: Guidant Corp-Cpi Division; 4100 N Hamline Ave; St Paul MN 55112-5798
• For Additional Information Contact: Nicholas J. Horvath, RAC; 651-582-4410
• Manufacturer Reason for Recall: Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.
• FDA Determined Cause: Other
• Action: On June 23, 2003, sales representatives began retrieving any recalled pacemakers, which were not implanted. For implanted pacemakers, an 'Important Patient Management Information' letter, dated June 23, 2003, was sent to physicians recommending that pacemaker-dependent patients, with the potentially affected pacemakers, be scheduled for exams to check for proper pacemaker performance using a programmer.
• Quantity in Commerce: 12 pacemakers
• Distribution: Nationwide in the United States and worldwide.
• 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.