Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets — Class II medical device recall Z-0524-2015
Terminated recall by Medtronic MiniMed Inc., reported 2014-12-17, distributed nationwide. Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion set
| Recall number | Z-0524-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed Inc., Northridge, CA, United States |
| Recall initiated | 2014-11-04 |
| Classified | 2014-12-08 |
| Reported by FDA | 2014-12-17 |
| Terminated | 2015-03-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BM, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, IE, IL, IN, IR, IS, IT, JO, JP, KE, KR, KW, LB, LT, LU, MA, MX, MY, NI, NL, NO, NZ, OM, PA, PH, PL, PT, PY, QA, RO, SA, SE, SG, SI, SK, SV, TH, TR, TW, UA, VE, ZA |
| Reason classes | device malfunction |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0524-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.