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# Medtronic MiniMed Recall Due to Labeling Design
- URL: https://www.fdaweb.com/medtronic-minimed-recall-due-to-labeling-design/
- Published: 2022-04-08T12:00:00.000Z
- Updated: 2026-09-14T17:39:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151553

FDA says Medtronic has recalled certain MiniMed 630G insulin pumps with SmartGuard due to a labeling design error. The pumps are intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for managing Type 1 diabetes mellitus in patients 16 years of age and older.

A [recall notice](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=192128&ref=fdaweb.com) says that 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” and potential severe hyperglycemia, the notice says.

FDA says current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting 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,” it says.