Major medical device manufacturing company Medtronic has announced a US Food and Drugs Administration (FDA) class I recall of its MiniMed insulin pump system.  This announcement comes during continued weak performance from Medtronic’s diabetes care division.

The company identified a defect relating to battery life and pumps being dropped or hit, leading to the recall of approximately 785,000 devices. The recall affects pump systems from the MiniMed 600 and 700 lines of insulin pumps, and Medtronic has already reported 181 adverse events because of the defect.

Insulin pumps are medical devices used to treat patients with diabetes. They administer small doses of insulin throughout the day and night. Most insulin pumps, including Medtronic’s, are battery-powered and use an AA battery. However, if there is damage to the battery casing, the insulin pump may fail to warn the user about a low battery, resulting in a lack of insulin being delivered to the patient. This can result in hyperglycaemia and diabetic ketoacidosis, both of which can be life-threatening. As such, ensuring that insulin pumps do not have these points of failure is very important.

According to the GlobalData Medical Intelligence Center, the US traditional insulin pump market will be worth $953 million in 2024, growing at a compound annual growth rate (CAGR) of 3.19%. Worldwide, the traditional pump market is valued at $2.6 billion and is growing at a CAGR of 7.12%. Medtronic holds a large share of this market; however, the company faces competition from other diabetes device manufacturers, such as Tandem Diabetes Care. This recall could cause patients to lose trust in Medtronic, potentially reducing its market share.

The recall has already impacted Medtronic’s stock performance. Medtronic’s diabetes division has been operating at a loss since 2022, as its devices have failed to meet patient expectations. Competing companies have intensified their own research and product development to market superior products.