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Terminated

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.

FDA Recall Z-0524-2015 · Posted 2014-12-12

Recalling FirmMedtronic MiniMed Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2014-11-04
Date Terminated2015-03-10
Product QuantityUS 12,400,098 and Internationally 8,266,733

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).

Firm 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.

Root Cause

Process change control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041545CONTACT DETACHUnomedical A/S · 2004-06-30K002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380Maersk Medical A/S · 2000-08-29

Official Source

View FDA Recall →

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

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