Recall Z-1741-2026— Medtronic MiniMed, Inc.

Name: FDA recall Z-1741-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-13

Class II · Ongoing

Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2026-02-13. It names one FDA 510(k) clearance: K251032. Product: MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896). 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..

Recalling firm: Medtronic MiniMed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-02-13
Firm location: Northridge, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K251032 — MiniMed 780G insulin pumpMedtronic Minimed, Inc.·cleared 2025-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.