The FDA announced February 11, 2020, that Medtronic recalled all 322,005 of its MiniMed insulin pumps in the United States. The agency issued a Class I Recall, which is the most serious type of recall reserved for situations where use of a medical device may cause serious injury or death. The recall comes on the heels of the first reported death caused by the device.
Insulin pumps regulate blood sugar in people with Type 1 diabetes. The device delivers small doses of short acting insulin continuously throughout the day, which replaces the traditional method of the patient periodically injecting him or herself with longer acting insulin. In operation, an insulin pump better recreates the function of a healthy pancreas.
The pump holds an insulin reservoir, from which insulin is slowly introduced into the body through a thin plastic tube that is permanently placed into the patient’s abdomen. The rate of flow is adjusted to maintain proper blood sugar levels. Insulin cartridges must be replaced periodically when the reservoir is depleted.