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Medtronic MiniMed, Inc. recalls Paradigm REF: MMT-712 and MMT-715

Recalled March 12, 2025 · FDA recall Z-1255-2025 · Medtronic MiniMed

Hazard
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. During a delivery accuracy dry run testing of the 780G NGP infusion pump under dynamic pressure conditions, the firm observed that when air pressure decreased during take-off simulation, on average 0.569U more insulin was delivered in 15 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate; when air pressure increased during landing simulation, on average 0.537 U less insulin was delivered in 25 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate. The firm also observed that the mechanisms causing the variations in delivery volumes are independent of the delivery rate. · FDA Class II
Units
20,760 units
Sold at
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of Algeria, Andorra, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Plurinational State Of Bosnia, Herzegovina , Botswana, Brazil, Brunei, Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Cayman, Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic Of Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malawi, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Republic Of Montenegro, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Northern Ireland, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion Romania, Russia, Saint Pierre And Miquelon, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Tanzania, United Republic Of Thailand, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian Republic Of Vietnam, Yemen, Zimbabwe.

Description

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. During a delivery accuracy dry run testing of the 780G NGP infusion pump under dynamic pressure conditions, the firm observed that when air pressure decreased during take-off simulation, on average 0.569U more insulin was delivered in 15 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate; when air pressure increased during landing simulation, on average 0.537 U less insulin was delivered in 25 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate. The firm also observed that the mechanisms causing the variations in delivery volumes are independent of the delivery rate.

Product
Paradigm REF: MMT-712 and MMT-715
Manufacturer(s)
Medtronic MiniMed, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Medtronic MiniMed, Inc. recalls Paradigm REF: MMT-712 and MMT-715 | RecallWatchUSA