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Serious riskFDA DeviceClass II

Medtronic MiniMed 770G insulin pumps recalled for dosing error risk

Medtronic MiniMed insulin pumps may deliver too much or too little insulin depending on whether the pump is held above or below the infusion site on your body. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar. This happens because gravity affects how insulin flows through the pump.

From the FDA notice · Read the official notice ↗ · All Medtronic recalls

What to do

  1. Keep your pump at approximately the same height as your infusion site (where the needle enters your skin) during normal use
  2. Contact Medtronic or your healthcare provider for guidance on safe pump positioning for your specific infusion site location
  3. Monitor your blood sugar more closely than usual and watch for signs of very high or very low blood sugar
  4. Do not stop using your pump without speaking to your doctor first
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Sold in
Nationwide
Made for
All ages

This recall covers 14 products — see all of them.

Details

Units affected
95,704
Illnesses reported
None reported
Manufactured in
18000 Devonshire St, Northridge, CA, United States
Classification
Class II
Recall number
Z-1742-2026

In the FDA's words

Description
MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892) 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. Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 770G Insulin Pump: 763000456634, 763000414344, 763000413750, 763000545604, 763000586188, 763000642242, 763000926113, 763000482602, 763000416553, 763000439903, 763000416546, 763000439910, 763000629892, 763000629908, 00763000595906, 763000412685, 763000418151, 763000416546, 763000439903, 763000545499, 763000595906, 763000545505, 763000629892, 763000642235, 763000414344, 763000413750, 763000439866, 763000413750, 763000586195, 763000545604, 763000578640, 76300058618802, 76300058619501, 76300057864002, 76300054560402, 76300058619502, 763000926113: For MiniMed 770G System Users Ages 2-13(M010831C001 1); MiniMed 770G SYSTEM USER GUIDE(M984970A002 1, M978700A002 1, M030281C001 3, M030281C002 1, M811470A261 2, M984970A004 1, M020090C001 3, M020090C002 1, M020090C003 1, M998590A012 2, M998590A003 1, M998590A004 1); MiniMed 770G SYSTEM USER GUIDE mmol/L(M000039C021 1, M811470A021 2). Distribution: 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 quantity: 95,704
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.

14 products in this recall

Medtronic MiniMed insulin pumps recalled for dosing error risk

Medtronic is recalling 14 MiniMed insulin pump models, including the Paradigm, 600 series, and BLE 700 series. Changes in pump height relative to the infusion site can cause the pump to deliver too much or too little insulin. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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