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U.S. Department of Health and Human Services

Class 2 Device Recall Guidant

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  Class 2 Device Recall Guidant see related information
Date Initiated by Firm June 23, 2003
Date Posted July 15, 2003
Recall Status1 Terminated 3 on July 02, 2004
Recall Number Z-1010-03
Recall Event ID 26561
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
Product Pulsar Max II Multiprogrammable Pacemaker, Model 1181
Code Information Serial number 811798   
Recalling Firm/
Guidant Corp-Cpi Division
4100 N Hamline Ave
St Paul MN 55112-5798
For Additional Information Contact Nicholas J. Horvath, RAC
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 2
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 1 pacemaker
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.