Medtronic plc, a leading medical device company, has initiated a recall for its MiniMed 600 and 700 insulin pumps due to potential battery life issues. This recall, classified as a Class I recall by the FDA, signifies the most serious type of recall due to the potential for adverse health consequences.
The recall stems from reports of shortened battery life in these pumps. Medtronic has linked this issue to pumps that have been dropped or impacted, which can damage internal electrical components. This damage may result in the pump stopping insulin delivery prematurely, potentially leading to dangerous complications such as hyperglycemia (high blood sugar) or diabetic ketoacidosis (DKA). DKA is a serious condition that occurs when the body lacks enough insulin to utilize blood sugar for energy.
Medtronic’s investigation has revealed that even a single drop can significantly reduce battery life, either immediately or over time. This issue persists even after replacing the battery. Furthermore, battery alerts and alarms may not provide adequate warning before the pump stops insulin delivery, increasing the need for users to replace the battery promptly upon receiving the “Low Battery Pump” alarm.
To mitigate the risks, Medtronic strongly recommends that users carry extra AA lithium, alkaline, or fully charged NiMH batteries.
The gravity of the situation is underscored by the number of reported incidents. Between January 2023 and September 2024, Medtronic received 170 reports of hyperglycemia exceeding 400 mg/dL and 11 reports of DKA in the United States, possibly related to this battery life issue.
Medtronic urges users experiencing shortened battery life to contact their local support team to determine if a replacement pump is necessary. It’s important to remember that this is not the first recall involving Medtronic’s insulin pumps. In 2021, the company expanded a Class I recall for its MiniMed 600 series pumps, offering replacements with a clear retainer ring.
This recall emphasizes the importance of vigilance and proactive measures in managing diabetes. Users of Medtronic’s MiniMed 600 and 700 pumps should closely follow Medtronic’s guidance and take the necessary precautions to ensure their safety and well-being.
