Z-1743-2026Class II

Medtronic MiniMed, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-04-08

Distribution

Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan, New Zealand, Australia, Bangladesh, Brunei Darussalam, Cambodia, Indonesia, Malaysia, Maldives, Philippines, Thailand, Vietnam, Singapore, Pakistan, Hong Kong, China, Argentina, Aruba, Barbados, Bermuda, Bolivia, Plurinational State Of, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, Puerto Rico, Trinidad And Tobago, Uruguay, Venezuela, Canada, South Korea, India, Albania, Algeria, Andorra, Armenia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guyana

Firm state

Product quantity

116,645

Initiated by

Voluntary: Firm initiated

Reason for recall

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Product description

MiniMed 640G Insulin Pump (MMT-1711, MMT-1712, MMT-1751, MMT-1752)

Code / lot info

Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 640G Insulin Pump: 643169999763, 763000002763, 763000002671, 643169999770, 763000002886, 643169729353, 763000002657, 763000002688, 763000002664, 763000002749, 763000002817, 763000002787, 763000002800, 763000002756, 763000002848, 763000002794, 763000002695, 763000002725, 763000002701, 763000002633, 763000002862, 643169729360, 763000002879, 763000002824, 763000002732, 763000002640, 763000002770, 763000002855, 763000002718, 763000002831, 763000065195, 763000065201, 763000083441, 763000015510, 763000015541, 763000015480, 763000015589, 763000015497, 763000068998, 763000015381, 763000015435, 763000015336, 763000015367, 763000069001, 763000015374, 763000015398, 763000015350, 763000192228, 763000015572, 763000015343, 763000015411, 763000015428, 763000015404, 763000015442, 763000015459, 763000015534, 763000015503, 763000194383, 763000194222, 763000194444, 763000194390, 763000194239, 763000198596, 763000194406, 763000194369, 763000015596, 763000194277, 763000194666, 763000194352, 763000198602, 763000192211, 763000194451, 763000015565, 763000194246, 763000194338, 763000194307, 763000194475, 763000194314, 763000155346, 763000194468, 763000194437, 763000194376, 763000194345, 763000194253, 763000194260, 763000194413, 763000194420, 763000192136, 763000192143, 763000165246, 763000165307, 763000165130, 643169629813, 763000194321, 763000194291, 763000165147, 763000165277, 763000165222, 763000165116, 763000165123, 763000165185, 763000165154, 763000165314, 763000165338, 763000165260, 763000165093, 763000165284, 763000165215, 763000165109, 763000165345, 763000258337, 763000258344, 763000317140, 763000319274, 763000319540, 763000319618, 763000317089, 763000319489, 763000319533, 763000319380, 763000319366, 763000319267, 763000319298, 763000319304, 763000319236, 763000319328, 763000319571, 763000319229, 763000319281, 763000319311, 763000319588, 763000319519, 763000319243, 763000347536, 763000319427, 763000404567, 763000319557, 763000319564, 763000319410, 763000319526, 763000319434, 763000319595, 763000319373, 763000319397, 763000402686, 763000319441, 763000319359, 763000319496, 763000319458, 763000404550, 763000402693, 763000317188, 763000317102, 763000317119, 763000319342, 763000402709, 763000317195, 763000367039, 763000367046, 763000317157, 643169554931, 643169554948, 643169554917, 643169629691, 643169554955, 643169629677, 643169629653, 643169629684, 643169554924, 643169629660, 643169596429, 643169521049, 643169596405, 643169521315, 643169522138, 643169577664, 643169577688, 643169577695, 643169596368, 643169596382, 643169521865, 643169596443, 643169520882, 643169662544, 643169672239, 643169672246, 643169672260, 643169672277, 643169672253, 643169662582, 643169682672, 643169662551, 643169662568, 643169681972, 643169662575, 643169683211, 643169682405, 643169682139, 643169682788, 643169682245, 643169739468, 643169739451, 643169739482, 643169739444, 643169739512, 643169739475, 643169682948, 643169999800, 643169721289, 643169668874, 643169999787, 763000115968, 763000013066, 763000074814, 763000074821, 763000192204, 763000192198, 763000253288, 763000324704, 763000324698, 763000324681, 00763000115968: MINIMED 640G SYSTEM USER GUIDE(MP6025958-116 1, MP6025958-393 1, M052248C002 1, M052249C002 1).

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →