{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192128", "product_res_number": "Z-0855-2022", "event_date_initiated": "2022-01-27", "event_date_created": "2022-03-31", "recall_status": "Open, Classified", "res_event_number": "89653", "product_code": "OZP", "pma_numbers": [ "P160017", "P150001" ], "product_description": "MiniMed 630G: MMT-1715, MMT-1754, MMT-1755;\nMiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782;\nMiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892;\nMiniMed 620G (OUS Only): MMT-1750;\nMiniMed 640G (OUS Only): MMT-1711, MMT-1712, MMT-1751, MMT-1752;\nMiniMed 720G (OUS Only): MMT-1809, MMT-1810, MMT-1859, MMT-1860;\nMiniMed 740G (OUS Only): MMT-1811, MMT-1812, MMT-1861, MMT-1862;\nMiniMed 780G (OUS Only): MMT-1884, MMT-1885, MMT-1886, MMT-1895, MMT-1896\n\nThe MiniMed\" 630G System with SmartGuard is intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons sixteen years of age and older.", "code_info": "Insulin pumps distributed in the last 6 months.\nAll devices (US) serial numbers ranging from NG2056884H TO NG2891033H and (OUS) serial numbers ranging from NG1921788H TO NG2883091", "firm_fei_number": "3003166194", "recalling_firm": "Medtronic MiniMed", "address_1": "18000 Devonshire St", "city": "Northridge", "state": "CA", "postal_code": "91325-1219", "additional_info_contact": "818-576-4700", "reason_for_recall": "New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.", "root_cause_description": "Labeling design", "action": "On 01/27/22, correction notices were sent to patients, healthcare providers, and distributors who were asked to do the following:\n1) Consult with your healthcare professional to determine the settings before using the pump.\n2) Existing Users with replacement or upgrade devices should:\n- Verify current basal rate pump settings. See user guide Viewing your basal information section. Settings can be saved on CareLink or written down on a paper.\n- If the basal rate settings are not present on your pump, please take all the following actions:\nLocate pump settings and consult with your healthcare professional to verify the most recent settings. If previous settings were uploaded to CareLink within 90 days, log into CareLink Personal, navigate to Reports , then Select custom range to choose a week that had the previous pump s upload, select DEVICE SETTINGS SNAPSHOT , and select Generate reports . Settings should have a non-zero basal rate.\nRefer to the user guide for detailed pump programming instructions. When programming basal rate settings, scroll down to select Done and then select Save on the next screen to activate the basal rate settings. Settings successfully saved when the message Changes saved .\nCustomers requiring assistance can call Technical Support at 1-800-646-4633, option 1.\nComplete/return the confirmation form.\nDistributors were provided with the Patient and Healthcare Provider letters, and asked to 1) notify their customers and provide status updates to the recalling firm, or 2) provide the recalling firm with their customer list so the recalling firm can provide the correction information to customers directly.\nMiniMed Pump Basal Setting Programming Support [medtronicdiabetes.com/basal-setting-support]; CareLink Personal [carelink.minimed.com]; User Guides/Manuals, [medtronicdiabetes.com/630g-user-guide], [medtronicdiabetes.com/670g-user-guide], [medtronicdiabetes.com/770g-user-guide].", "product_quantity": "175,801", "distribution_pattern": "US: OH, UT, IL, NY, FL, LA, NE, NV, CA, VA, TX, DE, KS, MS, MI, AL, OK, AZ, SC, IN, AR, PA, WV, MA, RI, NJ, CO, TN, KY, GA, WI, MN, NM, MD, IA, NC, WY, MO, WA, OR, CT, ND, ME, VT, ID, SD, AK, MT, NH, DC, HI, PR, VI\n\nOUS: Australia, Japan, Korea, New Zealand, Taiwan, Viet Nam", "openfda": { "pma_number": [ "P160017" ], "registration_number": [ "3004167884", "3009171251", "3011393376", "3014498598", "3006371704", "3012118659", "3009882464", "3014353045", "1037998", "2134850", "3038419886", "3042027705", "2032227", "1000134386", "3011121740", "1810909" ], "fei_number": [ "3004167884", "3006371704", "3011393376", "3014498598", "3012118659", "3042027705", "3009882464", "3014353045", "3006759904", "1037998", "3038419886", "3010700165", "3003166194", "1000134386", "3003007876", "1810909" ], "device_name": "Automated Insulin Dosing Device System, Single Hormonal Control", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }