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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic MiniMed Paradign Insulin Infusion Pumps

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 Class 2 Recall
Medtronic MiniMed Paradign Insulin Infusion Pumps
see related information
Date Posted July 07, 2007
Recall Status1 Open
Recall Number Z-1007-2007
Recall Event ID 37944
Premarket Notification
510(K) Numbers
K001829  K030531  K031390  K040676  K053177 
Premarket Approval
PMA Number
P980022/S016
Product Classification Pump, Infusion, Insulin - Product Code LZG
Product Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
Code Information "All serial numbers" for the following Paradigm models: MMT-51 1, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722
Recalling Firm/
Manufacturer
Medtronic MiniMed
18000 Devonshire St
Northridge, California 91325-1219
For Additional Information Contact Mark Faillace
818-576-5616
Manufacturer Reason
for Recall
Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi
Action Firm mailed Medical Device Safety letters on April 24, 2007, to healthcare professionals, existing pump users and MRI facilities reiterating the existing warning in the pump User Guide to avoid exposing the pump to MRI (or similar high strength electromagnetic fields) and strengthening previous warning by specifically mentioning the potential for over-delivery and severe hypoglycemia. Firm is also including an insert with this information with any Paradigm infusion pumps shipped to new customers.
Quantity in Commerce 334,000 Paradigm insulin pumps (approx)
Distribution Worldwide: USA, US Virgin Islands, Antigua, Australia, Austria, Bahamas, Bahrain, Bermuda, Brazil, Canada, Chile, China, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = LZG and Original Applicant = MEDTRONIC MINIMED
510(K)s with Product Code = LZG and Original Applicant = MINIMED, INC.
PMA Database PMAs with Product Code = LZG and Applicant = MEDTRONIC MINIMED
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