{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 14 } }, "results": [ { "cfres_id": "217834", "product_res_number": "Z-1739-2026", "event_date_initiated": "2026-02-13", "event_date_posted": "2026-04-02", "recall_status": "Open, Classified", "res_event_number": "98186", "product_code": "OZP", "pma_numbers": [ "P160017" ], "product_description": "MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)", "code_info": "Pump: UDI-DI(GTIN): User Guide Name(Part-Version):\nMiniMed 670G Insulin Pump: 643169946057, 763000096984, 763000090203, 763000165468, 763000190460, 763000190453, 763000216481, 763000187422, 763000187415, 763000165413, 763000165475, 763000367657, 763000289065, 763000264710, 763000283476, 763000283544, 763000283520, 763000283445, 763000393786, 763000289058, 763000374532, 763000283537, 763000365899, 763000371937, 763000283513, 763000165451, 763000165420, 763000165444, 763000165437, 763000165499, 763000165482, 763000165536, 763000165512, 763000165550, 763000165529, 763000235772, 763000165505, 763000235765, 763000165543, 763000257309, 763000283568, 763000283599, 763000289041, 763000289089, 763000289195, 763000289072, 763000289119, 763000289188, 763000289133, 763000289126, 763000289171, 763000289102, 763000404543, 763000289096, 763000289164, 763000404536, 763000324797, 763000264727, 763000324780, 763000283551, 763000283582, 763000374518, 763000374525, 763000374556, 763000374624, 763000374594, 763000374600, 763000399849, 763000399856, 763000408916, 763000408947, 763000371944, 763000365905, 763000374587, 763000408930, 763000283575, 763000157463, 763000203313, 763000252076, 763000283506, 763000411787, 643169946057, 763000096984, 763000190453, 763000283445, 763000395858, 763000278427, 763000090203, 763000283513, 763000365882, 763000283506, 76300028351303, 763000393786, 76300028351301, 763000166526, 643169939202, 763000190460, 763000283520, 763000072537, 763000256821, 643169939219, 763000187415, 763000283568:\n\nMiniMed670G System User Guide(M979513A011 1);\n\nMINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1);\n\nMINIMED 670G SYSTEM USER GUIDE(M988666A021 1, M979513A011 1, M985214A021 1, M985214A261 1, M974439A181 1, M974439A062 1, M974439A032 1, M974439A043 1, M974439A073 1, M974439A103 1, M974439A052 1, M020098C001 3, M020098C003 1, M974439A165 1, M974439A093 1, M974439A083 1);\n\nMINIMED 670G SYSTEM USER GUIDE mg/dL(M974449A111 1, M974449A073 1, M974449A103 1, M974449A023 1, M974449A093 1, M974449A083 1, M974449A113 1);\nMINIMED 670G SYSTEM USER GUIDE mmol/L(M974439A024 1).", "firm_fei_number": "3003166194", "recalling_firm": "Medtronic MiniMed, Inc.", "address_1": "18000 Devonshire St", "city": "Northridge", "state": "CA", "postal_code": "91325-1219", "additional_info_contact": "Medtronic 24-Hr Technical Support\n855-587-4950", "reason_for_recall": "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.", "root_cause_description": "Device Design", "action": "On 2/13/2026, communications began via email, SMS, certified postal mail, and in-app push notifications. Correction notices were sent informing customers of the following:\n\nUser Guides will be updated to include: \"It is important to keep the location of your pump stable relative to your infusion site. Do not wear or place your pump more than 14 in (35.5 cm) above your infusion site. Doing so can cause an over-delivery of insulin, which may result in hypoglycemia.\"\n\nUser guides that are updated will be available at: https://www.medtronicdiabetes.com/download-library\nvisit https://info.medtronicdiabetes.com/pump-placement for affected user\nguide versions.\n\nRequired Actions:\nKeep the location of your insulin pump close to your infusion site.\n- If you need to raise the pump above your infusion site, such as when a parent or\ncaregiver is using the pump for a child, limit the time that the pump is held above\nthe infusion site.\n- Pay attention to any alerts from your pump as well as symptoms of hypoglycemia\nand hyperglycemia; follow your healthcare professional's treatment instructions\nin these situations.\n- If you have any concerns about how this may impact insulin delivery and blood\nglucose, please contact your healthcare professional. You may also contact firm at\n1-855-587-4950 with any questions about this notification.\n-Complete and return the acknowledgement form by visiting https://info.medtronicdiabetes.com/pump-placement\n\nDistributor Partner / Service Provider: Send existing patients the Patient Notification. To HCPs send the HCP Notification and Patient Notification", "product_quantity": "84,248", "distribution_pattern": "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.", "openfda": { "pma_number": [ "P160017" ], "registration_number": [ "3009882464", "2032227", "3014498598", "3011393376", "1810909", "3042027705", "1000134386", "3011121740", "2134850", "1037998", "3004167884", "3014353045", "3038419886", "3009171251", "3012118659", "3006371704" ], "fei_number": [ "3009882464", "3003166194", "3014498598", "3011393376", "1810909", "3042027705", "3010700165", "3006759904", "1000134386", "1037998", "3004167884", "3003007876", "3014353045", "3038419886", "3012118659", "3006371704" ], "device_name": "Automated Insulin Dosing Device System, Single Hormonal Control", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }