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Serious riskFDA DeviceClass II

Medtronic MiniMed 720G insulin pump recalled for dosing error risk

Medtronic MiniMed insulin pumps (including MiniMed 720G, Paradigm, 600, and 700 series) can deliver too much or too little insulin depending on whether the pump is positioned above or below the infusion site. Too much insulin can cause dangerously low blood sugar, while too little can cause dangerously high blood sugar.

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

What to do

  1. Contact Medtronic immediately at 1-800-MINIMED (1-800-646-4633) or visit their website for instructions
  2. Do not stop using your pump without medical guidance—speak with your diabetes care team first
  3. Keep your pump at approximately the same height as your infusion site to reduce risk
  4. Monitor blood sugar levels closely and watch for signs of low blood sugar (shakiness, sweating, confusion) or high blood sugar (thirst, frequent urination)
Call · 800-646-4633Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 14 products — see all of them.

Details

Units affected
37,458
Illnesses reported
None reported
Manufactured in
18000 Devonshire St, Northridge, CA, United States
Classification
Class II
Recall number
Z-1745-2026

In the FDA's words

Description
MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) 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 720G Insulin Pump: 763000854768, 763000505196, 763000505219, 763000505318, 763000505257, 763000505295, 763000505233, 763000505370, 763000505325, 763000505332, 763000505394, 763000505356, 763000505387, 763000505349, 763000505400, 763000505226, 763000505271, 763000638016, 763000531171, 763000854751: MINIMED 720G SYSTEM USER GUIDE(M000187C022 1, M000186C002 1, M000186C014 1, M000187C016 1, M000186C021 1, M000186C018 1, M000186C017 1, M000187C010 1, M000187C011 1, M000186C031 1, M000187C013 1, M000187C008 1, M000187C015 1, M000187C005 1, M000187C033 1, M000186C028 1, M000187C023 1, M000187C020 1, M000187C018 1, M000186C018 13, M000186C004 1, M000186C030 1, M000186C009 1, M000187C024 1, M000186C033 1, M000186C003 1, M000187C012 1). 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: 37,458
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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