Medtronic MiniMed insulin pumps FDA Class I recalled for incorrect insulin dosing

Feb. 13, 2020

Medtronic is recalling the specified MiniMed 600 Series Insulin Pumps due to a missing or broken retainer ring that helps to lock the insulin cartridge into place in the pump's reservoir compartment. The Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall because these devices may cause serious injuries or death.

If the devices’ cartridge is not locked firmly into place, under or over delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. Severe hyperglycemia can result in a loss of consciousness, seizure, and death.

MiniMed 600 Series Insulin Pumps models are:

·        Model 630G (MMT-1715) - all lots before October 2019, and Model 670G (MMT-1780) - all lots before August 2019

·         Distribution Dates: Model 630G - September 2016 to October 2019, Model 670G - June 2017 to August 2019

The total devices recalled in the U.S. are 322,005. The firm has received a total of 26,421 complaints in which the device malfunctioned in this manner. The firm is aware of 2,175 injuries and one death.

On November 21, 2019 Medtronic notified affected customers and advised them to:

·         Examine the retainer ring of their pump.

·         Stop use of the pump and contact Medtronic for a replacement pump if the reservoir does not lock into the pump or if the retainer ring is loose, damaged, or missing. If you stop using the pump, you should follow your doctor's recommendations and perform manual insulin injections.

·         Continue using the pump if the reservoir locks in place correctly.

·         If the pump is dropped by accident, check the pump and retainer ring for damage and stop use if it is damaged.

·         Check the pump retainer ring and verify that the reservoir is locked correctly at every set change.

FDA has the announcement.