• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall MiniMed Model 512 Insulin Infusion Pumps

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 3 Device Recall MiniMed Model 512 Insulin Infusion Pumps see related information
Date Initiated by Firm September 14, 2004
Create Date June 25, 2015
Recall Status1 Terminated 3 on March 03, 2005
Recall Number Z-0011-05
Recall Event ID 30059
Product Classification Pump, Infusion, Insulin - Product Code LZG
Product Medtronic 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/
Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact
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
Distribution Nationwide & Spain
Total Product Life Cycle TPLC 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.