Z-0524-2015Class II

Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368...

Name: Z-0524-2015 Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368...
Creator: Medtronic MiniMed Inc.
Published: 2014-11-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-11-04 / Terminated

FDA source

Medtronic MiniMed Inc. began a recall of Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377... on 2014-11-04. FDA classified it as Class II and gives the reason as "Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0524-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Posted: 2014-12-12
Terminated: 2015-03-10
Recalling firm: Medtronic, Inc.
Product: Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382600, MMT-383, MMT-383600, MMT384, & MMT384600. Sure-T infusion sets MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-873, MMT-874, MMTMMT-875, MMT-876, MMT-884, & MMT-886. MiniMed Duo sensor/infusion sets: MMT-5001A23, MMT-5001A43, MMT-5001B23, MMT-5001B43, MMT-5011A23, MMT-5011A43, MMT-5011B23, & MMT-5011B43. Silhouette and Sure-T disposable infusion sets are used with Medtronic insulin infusion pumps using Paradigm P-cap connectors. The infusion set connects the insulin reservoir in the pump to the patients body.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to hyperglycemia, and diabetic ketoacidosis (DKA).
FDA root cause: Process change control
Action: Medtronic sent an Urgent Medical Device Correction letter to patients dated November 5, 2014, healthcare professionals October 30, 2014, and distributors October 2014. Call the Medtronic 24-Hour HelpLine at 866.222.7304 to report the issue. Medtronic will give you instructions on how to return the affected infusion set. The letter states that Medtronic has identified a solution and is working to incorporate improvements within the coming weeks. In the meantime, you will still be able to order these infusion sets. If you would like to try another type of infusion set instead, we can exchange your infusion sets with the MiniMed Quick-set or MiniMed Mio. To learn more about these infusion sets or to find additional information about this notification, please call us or visit www.medtronicdiabetes.com/tubingdetachment.
Quantity in commerce: US 12,400,098 and Internationally 8,266,733
Distribution: Worldwide distribution: US (Nationwide) and countries of: Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lativa, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Venezuela.
Product codes and lots: This field correction involves all models of Silhouette and Sure-T insulin infusion sets.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0524-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0524-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-17	2014-12-08

Product code FPA

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)