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U.S. Department of Health and Human Services

Class 3 Device Recall MiniMed Model 512 Insulin Infusion Pumps

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 Class 3 Device Recall MiniMed Model 512 Insulin Infusion Pumpssee related information
Date Initiated by FirmSeptember 14, 2004
Create DateJune 25, 2015
Recall Status1 Terminated 3 on March 03, 2005
Recall NumberZ-0011-05
Recall Event ID 30059
Product Classification Pump, Infusion, Insulin - Product Code LZG
ProductMedtronic MiniMed Paradigm Model 512
Code Information Paradigm model 512pumps with serial numbers that end in '-Axx4' . Where 'x' can be any number or letter.
Recalling Firm/
Manufacturer		 Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact
800-646-4633
Manufacturer Reason
for Recall		Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish.
FDA Determined
Cause 2		Other
DistributionNationwide & Spain
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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