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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmNovember 04, 2002
Date PostedDecember 18, 2002
Recall Status1 Terminated 3 on December 14, 2004
Recall NumberZ-0341-03
Recall Event ID 25102
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
ProductPulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-036-1 Meta, Model 1256
Code Information Serial numbers U6227335 to U6240907
Recalling Firm/
Manufacturer		 St Jude Medical
15900 Valley View Court
Sylmar CA 91342
For Additional Information ContactLarry Selznick
800-722-3774
Manufacturer Reason
for Recall		Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1
FDA Determined
Cause 2		Other
ActionFirm issued 'Dear Doctor' letters to following physicians which listed patient''s that the Doctor was responsible for. The letter informs of the situation regarding the potential loss of pacing function and recommends that the professional healthcare provider review and evaluate patients with the affected devices as soon as possible. Additional conditions to consider are specified for pacemaker dependent versus nondependent patients.
Quantity in Commerce1146
DistributionNationwide and Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Rep., France, Germany, Italy, Netherlands, Spain, Turkey, Venezuela.
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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