Date Initiated by Firm | May 06, 2003 |
Date Posted | May 29, 2003 |
Recall Status1 |
Terminated 3 on November 18, 2005 |
Recall Number | Z-0877-03 |
Recall Event ID |
26235 |
Product Classification |
Implantable Pacemaker Pulse-Generator - Product Code DXY
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Product | Pulsar Multiprogrammable Pacemaker, DDD Model 976 |
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 |
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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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