Medtronic Issues Voluntary Recall Alerting Insulin Pump Users About Possible Risks Associated with Reduced Battery Longevity

Summary

Company Announcement

Customers are being reminded to regularly check built-in alerts and alarms for battery status and to reach out to Medtronic for pump replacements if they are affected by this matter.

GALWAY, Ireland – October 4, 2024 – Medtronic plc (NYSE: MDT), a prominent name in healthcare technology, has initiated a field action as of July 31, 2024, to inform global customers using its MiniMed™ 600 series or 700 series insulin pumps to adhere to the device’s battery alerts. The company investigated this issue following customer feedback regarding reduced battery life. Their comprehensive analysis indicated that pumps subjected to drops, bumps, or any physical impacts—even just once—may experience internal electrical damage resulting in a shorter battery life. This fault may lead to alerts indicating battery issues when there is actually less battery life than stated in the User Guide, which could disrupt insulin delivery and pose health risks such as hyperglycemia or diabetic ketoacidosis (DKA), potentially necessitating medical intervention. From January 2023 to September 2024, Medtronic recorded 170 hyperglycemia incidents exceeding 400 mg/dL and 11 diabetic ketoacidosis cases in the U.S. connected to this problem. Accordingly, the FDA has categorized this issue as a class I recall.

The company released an updated notice to customers with the following points:

• A single drop could diminish battery life either instantly or over time, and the problem may persist even after replacing the battery.
• Battery alerts and alarms may continue to sound, but they might not reflect the actual battery life remaining before insulin delivery halts. Users should be ready to replace the battery promptly when the “Low Battery Pump” alarm is activated.
• Customers should always have extra new AA lithium or alkaline batteries handy, or ensure their NiMH batteries are fully charged for unexpected replacements.
• If users perceive a significant battery life reduction, they should contact their local Medtronic team to assess if a replacement pump is essential. U.S. customers can obtain 24-hour technical support by calling 1-800-378-2292, while those outside the U.S. can find local contact numbers at this link.
• It is recommended that users maintain a back-up therapy option in case it becomes necessary.

“Medtronic actively began notifying affected pump users in July, prioritizing patient safety and acknowledging the critical role of pumps in diabetes management,” stated Robert Vigersky, MD, Chief Medical Officer of Medtronic Diabetes. “Our support team is available 24/7 to assist those facing battery depletion or any concerns with their pump. Ensuring patient safety and continuity of therapy is paramount, which is why we made the proactive decision to reach out to patients and will provide replacements as needed.”

For more details, the original notification along with the updated information is available on the Medtronic Diabetes website.

About Medtronic’s Diabetes Division (www.medtronicdiabetes.com) – Medtronic collaborates with the global community to change diabetes management. The company is dedicated to enhancing diabetes care by broadening access, integrating services, and improving patient outcomes, enabling better health and freedom for individuals living with diabetes.

About Medtronic
Medtronic is at the forefront of addressing major health challenges, pursuing innovative solutions with a mission to relieve pain, restore health, and prolong life. Headquartered in Galway, Ireland, the company consists of over 95,000 committed professionals operating in more than 150 countries. The range of their technologies and therapies includes cardiac devices, surgical robotics, insulin pumps, and more. Driven by a desire to support those in need, Medtronic impacts lives every second of every day. Explore Medtronic’s initiatives on their website, www.Medtronic.com, and connect with them on LinkedIn.

Cautionary Statement: Any forward-looking statements are often subject to uncertainties and risks detailed in Medtronic’s periodic reports filed with the Securities and Exchange Commission. Actual results may substantially differ from projected outcomes.