FDA Device recall Z-0524-2015
Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets
- FDA Device
- Class II
- terminated
- Published 2014-12-17
On 2014-12-17 the FDA classified a Class II recall of Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets by Medtronic Minimed, citing 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 n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0524-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-04 |
| Published | 2014-12-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Minimed |
| Distribution | US |
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.
Reason
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).
Identifiers
| code_info | This field correction involves all models of Silhouette and Sure-T insulin infusion sets. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0524-2015%22
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