The FDA has issued a Class I recall, the most serious type, for the Medtronic MiniMed 600 and 700 series insulin pumps, citing reduced battery life risk and unexpected insulin delivery interruptions.

According to a press release from the FDA, Medtronic received 170 reports of hyperglycemia (>400 mg/dL) and 11 reports of diabetic ketoacidosis between January 2023 and September 2024 due to this issue. The increased likelihood of reduced battery life or quicker shutdown following a battery alert could lead to insulin delivery stopping sooner than expected, with potential risks of hyperglycemia, diabetic ketoacidosis, or, in severe cases, death.

''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," said Robert Vigersky, MD, chief medical officer at Medtronic Diabetes.

The recall affects all lots and serial numbers for MiniMed 630G, 670G, 770G, and 780G models, according to the release. The FDA has classified this as a Class I recall due to potential adverse health consequences.

Medtronic advises that patients replace the battery immediately upon receiving a “low battery pump” alert. Those who receive the alert should not wait for additional battery alerts, as these may signal an even lower battery life than indicated in the user guide, according to the release.

It is also suggested that patients carry an extra set of AA batteries or fully charged NiMH batteries in case of an unexpected battery change.

Finally, patients are urged to contact Medtronic’s 24-hour Technical Support at 1-800-378-2292 if battery life changes significantly.

Affected Product

• Product Names: MiniMed 630G, 670G, 770G, 780G
• Model: See full list of affected devices.
• Lot/Serial Numbers: All lots and serial numbers

“Patient safety is our priority, as is continuity of therapy, which is why we made the decision to voluntarily notify patients and will replace pumps when needed,” Vigersky wrote.

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Disclosure: Vigersky is an employee of Medtronic.
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