Recall Z-1748-2026— Medtronic MiniMed, Inc.

Name: FDA recall Z-1748-2026
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 4 FDA 510(k) clearances: K120206, K053177, K040676 and 1 more. Product: Paradigm Insulin Pump (MMT-712, MMT-715). 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

4 on FDA's record

K120206 — MEDTRONIC MINIMED PARADIGM INSULIN PUMPSMedtronic Minimed·cleared 2012-03-29
K053177 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712EMedtronic Minimed·cleared 2006-01-31
K040676 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715Medtronic Minimed·cleared 2004-05-21
K031390 — MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712Minimed, Inc.·cleared 2003-07-23

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

Paradigm Insulin Pump (MMT-712, MMT-715)

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.