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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic MiniMed

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 Class 2 Device Recall Medtronic MiniMedsee related information
Date Initiated by FirmSeptember 09, 2003
Date PostedNovember 27, 2003
Recall Status1 Terminated 3 on September 02, 2005
Recall NumberZ-0169-04
Recall Event ID 27475
Product Classification Pump, Infusion, Insulin - Product Code LZG
ProductAmbulatory infusion pump. Model 511
Code Information No information at this time.
Recalling Firm/
Manufacturer		 Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information ContactMark Faillace
818-576 Ext. 5616
Manufacturer Reason
for Recall		Non delivery of insulin by pump after electrostatic discharge.
FDA Determined
Cause 2		Other
Quantity in Commerce17,000
DistributionNationwide Canada and possibly International
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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