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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 Guidantsee related information
Date Initiated by FirmMay 06, 2003
Date PostedMay 29, 2003
Recall Status1 Terminated 3 on November 18, 2005
Recall NumberZ-0881-03
Recall Event ID 26235
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
ProductPulsar Max II Multiprogrammable Pacemaker, DDDR Model 1284
Code Information All Serial numbers
Recalling Firm/
Manufacturer
Guidant Corp-Cpi Division
4100 N Hamline Ave
St Paul MN 55112-5798
For Additional Information ContactNicholas 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
ActionAn '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.
DistributionNationwide in the United States and worldwide.
Total Product Life CycleTPLC 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.
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