Recall Z-1745-2026— Medtronic MiniMed, Inc.

Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2026-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867). 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

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