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FDA-Device2026-04-08Class IIPROCESSING DEFECT

Medtronic MiniMed Paradigm insulin pumps recalled for incorrect insulin delivery based on pump position

Medtronic
OTHERNationwide distribution

Stop using Medtronic MiniMed Paradigm insulin pump

Medtronic MiniMed insulin pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is held at different heights relative to the infusion site. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and serious complications.

  • Contact Medtronic immediately for instructions on your specific pump model
  • Do not rely on your pump until you receive guidance from Medtronic
  • Work with your healthcare provider to establish a temporary insulin management plan
  • Keep your pump level with your infusion site when in use, and monitor blood sugar closely
Hazard

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.

Sold states
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, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan, New Zealand, Australia, Bangladesh, Brunei Darussalam, Cambodia, Indonesia, Malaysia, Maldives, Philippines, Thailand, Vietnam, Singapore, Pakistan, Hong Kong, China, Argentina, Aruba, Barbados, Bermuda, Bolivia, Plurinational State Of, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, Puerto Rico, Trinidad And Tobago, Uruguay, Venezuela, Canada, South Korea, India, Albania, Algeria, Andorra, Armenia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guyana, French Polynes., Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malawi, Malta, Martinique, Mauritius, Mayotte, Moldavia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Qatar, Reunion, Romania, Russia, San Marino, Saudi Arabia, Serbia, Sierra Leone, Slovakia, Slovenia, South Africa, Spain, St.Pier,Miquel., Sudan, Sweden, Switzerland, Syrian Arab Republic, Tanzania, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Yemen, Zambia, Zimbabwe.
Affected count
29,074
Manufactured in
18000 Devonshire St, Northridge, CA, United States
Products
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1749-2026

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