Medtronic MiniMed Paradigm Reservoirs — Class II medical device recall Z-1986-2013
Terminated recall by Medtronic MiniMed, reported 2013-08-28, distributed nationwide. Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.
| Recall number | Z-1986-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Northridge, CA, United States |
| Recall initiated | 2013-07-03 |
| Classified | 2013-08-20 |
| Reported by FDA | 2013-08-28 |
| Terminated | 2014-01-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BM, BR, CA, CL, DE, EC, JP, MX, PY, SG, SV, UY, VE |
| Quantity | 669,672 units |
| Reason classes | packaging |
| Lot numbers | H8416432, H8420977, H8422490, H8424676, H8437486, H8441420, H8442973, H8451531, H8452933, H8455959, H8457716, H8459557, H8461538, H8463297, H8464121, H8467888, H8469703, H8471745, H8473106, H8473271, H8476270, H8478398, H8485398, H8486688, H8489386, H8491921, H8492449, H8494645, H8496561, H8500423, H8500472, H8503372, H8503728, H8509305, H8510440, H8512566, H8512826, H8515317, H8517079, H8521052 and 8 more |
| Model numbers | MMT-326A, MMT-332A |
Product
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin capacity. The MMT-326A holds a maximum of 1.8ml of insulin whereas the longer MMT-332A reservoir can hold up to 3.0ml of insulin. Both reservoirs are supplied sterile and are labeled for single use. Typically, the reservoir is replaced every tow or three days at the time of infusion set replacement. The Paradigm reservoirs have a shelf life of three years post sterilization. Product Quantity Distributed (Int) 669,672 units
Reason for recall
Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs in the infusion set, the pump may not
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-1986-2013. 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.