Medtronic Minimed Paradigm Insulin Pump, Model Mmt-712

• • Ongoing Z-1748-2026 FDA Class II ·initiated 13 Feb 2026 ·on shared 510(k) K031390

  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.

• • Terminated Z-1007-2007 FDA Unclassified (pre-2012) ·initiated 27 Apr 2007 ·on shared 510(k) K031390

  Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver; potentially causing severe hypoglycemi

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K031390 ↗

FDA Product Code

LGZ

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Minimed, Inc. →