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Terminated

Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.

FDA Recall Z-1668-2013 · Posted 2013-07-09

Recalling FirmMedtronic MiniMed
Recall StatusTerminated
Product CodeFPA
Date Initiated2013-06-07
Date Terminated2015-06-10
Product Quantity11,000,000 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011071PARADIGM QUICK-SET INFUSION SETMaersk Medical A/S · 2001-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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