RecallCheckr

Serious recall: Injury is possible or has been reported. Take action promptly.

Medtronic MiniMed, Inc. 2026-04-08 Health serious FDA
Health · FDA · Recall #FDA-Z-1749-2026

Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) Recall

Issued April 8, 2026 · Medtronic MiniMed, Inc.

In April 2026, Medtronic MiniMed, Inc. recalled the Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722), a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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.

What you should do

  1. 1 Stop using Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Medtronic MiniMed, Inc. to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Medtronic MiniMed, Inc.
Category
Health
Recall date
April 8, 2026
Units affected
Not reported
Sold at
Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA
Recall number
FDA-Z-1749-2026
Made in
United States
Issuing agency
FDA

In context

  • Medtronic MiniMed, Inc. has 7 recalls in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 356th Health recall we've logged in 2026.
Read the official FDA notice

Related recalls