Z-1668-2013Class I

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

Name: Z-1668-2013 Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with...
Creator: Medtronic MiniMed
Published: 2013-06-07
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-06-07 / Terminated / root cause: design

FDA source

Medtronic MiniMed began a recall of Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps on 2013-06-07. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1668-2013
Classification: Class I
Status: Terminated
Initiated: 2013-06-07
Posted: 2013-07-09
Terminated: 2015-06-10
Recalling firm: Medtronic, Inc.
Product: Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1668-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1668-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-09

Product code FPA

K011071Class IIParadigm Quick-Set Infusion SetMaersk Medical A/S / cleared 2001-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)