Class 2 Device Recall Guidant

Date Initiated by Firm	May 06, 2003
Date Posted	May 29, 2003
Recall Status¹	Terminated ³ on November 18, 2005
Recall Number	Z-0887-03
Recall Event ID	26235
Product Classification	Implantable Pacemaker Pulse-Generator - Product Code DXY
Product	Discovery II Multiprogrammable Pacemaker, DDDR Model 1283
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 ²	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.