Medtronic has announced a voluntary recall of MiniMed 600 series or 700 series insulin pumps due to their potentially shortened battery life.
The US Food and Drug Administration (FDA) has classified this recall as Class I, the most serious kind.
The healthcare technology company issued a voluntary field action in July. The safety alert letter highlighted the importance of the pump’s built-in alerts and alarms for battery status.
Medtronic instructed its users to contact the company in case they observe changes in the battery life of their pump.
The company has now sent an updated urgent medical device correction letter highlighting the potential reasons for the shortened pump battery life.
The affected product range includes MiniMed 630G, 670G, 770G, and 780G systems.
Medtronic started investigating the issue after receiving reports of shortened battery life. The analysis revealed that physical impacts, like dropping or bumping the pump, can damage internal components, leading to reduced battery life.
This electrical issue also causes battery alerts to appear when less battery life remains than the limit mentioned in the user guide.
According to the healthcare technology company, the damage can cause the pump to stop insulin delivery earlier than expected.
This malfunction poses health risks, including hyperglycaemia and diabetic ketoacidosis (DKA).
From January 2023 to September 2024, Medtronic received 170 reports of hyperglycaemia over 400 mg/dL and 11 reports of DKA related to this issue in the US.
Medtronic diabetes chief medical officer Robert Vigersky said: “Medtronic began proactively notifying impacted pump users in July because of the high priority we place on patient safety and understand the important role of pumps in the care and management of diabetes.”
Medtronic said that even a single drop of the pump can lead to reduced battery life. This effect can occur immediately or develop over time, and it will persist even after a battery replacement.
Users should be ready to replace the battery when they hear the Low Battery Pump alarm, said the healthcare technology firm, while advising to keep an extra set of batteries on hand.
The healthcare company also advised users to have a backup therapy option ready in case of emergency.
In June, Medtronic recalled its StealthStation S8 applications based on customer feedback highlighting a software glitch. The FDA also deemed that recall as Class I.
