FDA identifies recall of Medtronic’s MiniMed series pumps as Class I

Medtronic is notifying users of all MiniMed 600 and 700 series insulin pumps of an increased risk for reduced battery life and less time until shutdown after a battery alert occurs. Pumps that have been dropped, bumped, or experienced another physical impact may have damaged electrical components causing this issue—even a single drop can impact battery life. This may result in the pump stopping insulin delivery significantly sooner than usually expected.

The use of affected product may cause serious adverse health consequences, including high blood sugar (hyperglycemia), fat breaking down too fast in the body (diabetic ketoacidosis) and death.

From January 2023 to September 2024, Medtronic reports receiving 170 reports of hyperglycemia, >400mg/dL, and 11 reports of diabetic ketoacidosis related to this issue. There have been no reports of death.

Device use
MiniMed 600 and 700 series insulin pumps are battery operated, portable pumps that deliver insulin for the management of diabetes in persons requiring insulin. These pumps also receive, store and display blood sugar (glucose) values from a transmitting device. U.S. Food and Drug Administration