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Serious riskFDA DeviceClass II

Medtronic MiniMed 620G insulin pump recalled for dosing error risk

Medtronic MiniMed infusion pumps (Paradigm, 600, and 700 series) can deliver too much or too little insulin when the pump is raised or lowered relative to the infusion site. This happens because gravity affects pressure in the pump system. Too much insulin can cause dangerously low blood sugar; too little can cause dangerously high blood sugar and serious complications.

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

What to do

  1. Contact Medtronic MiniMed immediately for instructions on your specific pump model and serial number
  2. Do not change how you wear or position your pump until you speak with Medtronic
  3. Keep close watch on your blood sugar levels and symptoms of low or high blood sugar
  4. Have a backup insulin delivery plan ready (such as syringes or pens) in case you need to stop using your pump
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MiniMed 620G Insulin Pump (MMT-1750)
Sold in
Nationwide
Made for
All ages (under 120 years)

This recall covers 14 products — see all of them.

Details

Units affected
799
Illnesses reported
None reported
Manufactured in
18000 Devonshire St, Northridge, CA, United States
Classification
Class II
Recall number
Z-1747-2026

In the FDA's words

Description
MiniMed 620G Insulin Pump (MMT-1750) 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 620G Insulin Pump: 643169559745, 643169721319, 763000375461, 763000253189: Instr, Startup Guide, 620G 4.10, EN(6025951-022 1); INSTR., NGP 620G, BOLUS WIZARD, EN(6026006-023 1); Instr., 620G, Sftwr. 4.10, EN.(6026006-024 1); INSTRUCTIONS MMT-746EN PUMP 1510/1710 EN(7005933-023 1); DOC PKG MMT-746EN NGP 1710 EN(7005933-024 1); Startup Guide Assembly MMT-755EN(620G(M982438A021 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: 799
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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