Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600

FDA device recall Z-0524-2015 · posted 2014-12-12 · Terminated

Recall details

Recalling firm

Medtronic MiniMed Inc.

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).

Action taken

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.

Root cause

Process change control

Status

Terminated

Product code

FPA

Quantity affected

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, Croa

Date initiated

2014-11-04

Date posted

2014-12-12

Date terminated

2015-03-10

Location

Northridge, CA

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