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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic MiniMed Paradigm Insulin Infusion Sets

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  Class 1 Device Recall Medtronic MiniMed Paradigm Insulin Infusion Sets see related information
Date Initiated by Firm June 07, 2013
Date Posted July 09, 2013
Recall Status1 Terminated 3 on June 10, 2015
Recall Number Z-1668-2013
Recall Event ID 65430
510(K)Number K011071  
Product Classification Set, administration, intravascular - Product Code FPA
Product Medtronic MiniMed Paradigm Insulin Infusion Sets

The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Code Information This field correction involves models: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm Infusion sets.
Recalling Firm/
Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact
Manufacturer Reason
for Recall
Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin.
FDA Determined
Cause 2
Device Design
Action Medtronic, Inc. sent an Urgent Medical Device Safety Notification letter dated June 10, 2013, to all affected consignees. The letter identified the product and notified healthcare professionals of the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. The letter informed the consignees that it applies to all Medtronic infusion sets designed for use with Medtronic Paradigm family infusion pumps. Paradigm Insulin Pump users, distributors, and healthcare professionals were all instructed to contact Medtronic's 24 hour helpline at (888) 204-7616. For questions regarding this recall call 818-567-4700.
Quantity in Commerce 11,000,000 units
Distribution Worldwide distribution: US (nationwide) distribution: Algeria, Argentina, Australia, Bahamas, Bahrain, Bermuda, Boliva, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Southern Territories, Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Netherlands, Norway, New Zealand, Oman, Panama, Paraguay, Peru, Poland, Province of China, Taiwan, Qatar, Republic of Korea, Romania, Russia Federation, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, Uruguay, and¿Venezuela.
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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = MAERSK MEDICAL A/S