FDA Device recall Z-1740-2026
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) by Medtronic Minimed, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1740-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-13 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medtronic Minimed |
| Distribution | US |
Product
MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Reason
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.
Identifiers
| code_info | Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527…Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527, 763000190446, 763000317591, 763000157043, 643169752726, 763000101527, 763000190446, 763000317591, 643169873841, 643169878648, 763000179632, 76300031759101, 76300031759103, 76300031762103, 763000367091, 763000317621, 763000157043, 76300031762101: MiniMed 630G System(M020092C004 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MiniMed 630G Insulin pump MODEL MMT-1714(M993428A262 1); MiniMed 630G System User Guide(M020092C001 3, M020092C003 1, M020092C005 1); MINIMED 630G SYSTEM USER GUIDE mg/dL(M979512A011 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(MP6026120-262 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(M030278C001 3, M030278C002 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE mmol/L (MP6026120-024 1); MiniMed Veo with Enlite Threshold Suspend Performance(M10577668A262 1). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1740-2026%22
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