Reported Dec 17, 2014 · Terminated

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

Medtronic MiniMed Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic MiniMed Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219

Is this the product you have?

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 setsMMT-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

Lot codes and dates: This field correction involves all models of Silhouette and Sure-T insulin infusion sets.
Amount recalled: US 12,400,098 and Internationally 8,266,733

Where it was sold

Nationwide
PR

Why it was recalled

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).

This product could cause temporary or reversible health problems — stop using it.

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By hazard

Medical device recalls

Other recalls from Medtronic MiniMed Inc.

7 in total.

Where it was distributed

Puerto Rico recalls

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