Z-0855-2022Class II

MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761...

Name: Z-0855-2022 MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761...
Creator: Medtronic MiniMed
Published: 2022-01-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-01-27 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic MiniMed began a recall of MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed... on 2022-01-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0855-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-27
Posted: 2022-03-31
Recalling firm: Medtronic, Inc.
Product: MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS Only): MMT-1711, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G (OUS Only): MMT-1809, MMT-1810, MMT-1859, MMT-1860; MiniMed 740G (OUS Only): MMT-1811, MMT-1812, MMT-1861, MMT-1862; MiniMed 780G (OUS Only): MMT-1884, MMT-1885, MMT-1886, MMT-1895, MMT-1896 The 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.
Product code: OZP Automated Insulin Dosing Device System, Single Hormonal Control
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 tag: labeling and UDI
FDA root cause: Labeling design
Action: On 01/27/22, correction notices were sent to patients, healthcare providers, and distributors who were asked to do the following: 1) Consult with your healthcare professional to determine the settings before using the pump. 2) Existing Users with replacement or upgrade devices should: - 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. - If the basal rate settings are not present on your pump, please take all the following actions: Locate 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. Refer 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 . Customers requiring assistance can call Technical Support at 1-800-646-4633, option 1. Complete/return the confirmation form. Distributors 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. MiniMed 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].
Quantity in commerce: 175,801
Distribution: 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 OUS: Australia, Japan, Korea, New Zealand, Taiwan, Viet Nam
Product codes and lots: Insulin pumps distributed in the last 6 months. All devices (US) serial numbers ranging from NG2056884H TO NG2891033H and (OUS) serial numbers ranging from NG1921788H TO NG2883091

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0855-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0855-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-06	2022-03-31

Product code OZP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)