Class 2 Device Recall Guidant

• Date Initiated by Firm: May 06, 2003
• Date Posted: May 29, 2003
• Recall Status: Terminated on November 18, 2005
• Recall Number: Z-0895-03
• Recall Event ID: 26235
• Product Classification: Implantable Pacemaker Pulse-Generator - Product Code DXY
• Product: Insignia Entra Multiprogrammable Pacemaker, DDDR Model 1297
• Code Information: All Serial numbers
• Recalling Firm/ Manufacturer: Guidant Corp-Cpi Division; 4100 N Hamline Ave; St Paul MN 55112-5798
• For Additional Information Contact: Nicholas J. Horvath; 651-582-4410
• Manufacturer Reason for Recall: In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.
• FDA Determined Cause: Other
• Action: An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.
• 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.