Medtronic Alerts Users About Potential Risks Associated with MiniMed Insulin Pump Recall

This recall does not require the removal of all products. Users should reach out to Medtronic if they notice significant decreases in battery life to assess whether a new pump is necessary.  The FDA categorizes this recall as the most severe classification.

Products Involved 

• Product Names: MiniMed 630G, 670G, 770G, 780G 
• Model: Refer to the complete list of impacted devices.
• Lot/Serial Numbers: All lot and serial numbers

Figure: MiniMed 670G insulin pump    Figure: MiniMed 780G insulin pump
(MiniMed 630G and 670G pumps also affected but not displayed)

Recommended Actions  

• Replace the battery immediately upon receiving the “Low Battery Pump” alert. 
  • Do not postpone battery replacement, as subsequent alerts may come when battery levels are lower than what is specified in the User Guide.
• Keep spare batteries handy in case an unexpected battery change is necessary.
• Get in touch with Medtronic if you notice any changes in your pump’s battery life. 

On July 31, 2024, Medtronic sent a Safety Alert to all affected users, advising them to adhere to the alerts and alarms on their MiniMed 600 series and 700 series insulin pumps. If there are changes noted in battery life, users should contact Medtronic. 

In an UPDATE: Urgent Medical Device Correction letter on October 4, 2024, Medtronic recommended the following steps: 

• Have an extra supply of new AA lithium or alkaline batteries or fully charged NiMH batteries at the ready for early battery changes. 
• Be attentive to all pump alerts and signals.
• Change the battery immediately upon receiving the “Low Battery Pump” alert. 
  • Do not wait for further alerts as they could be triggered when the battery is already critically low. 
  • Follow the User Guide for proper battery replacement instructions. 
• Note that when the “Replace Battery Now” warning appears, insulin dispensing ceases.
• Contact Medtronic’s 24-Hour Technical Support at 1-800-378-2292 to evaluate if a pump replacement is necessary if any substantial drop in battery life occurs, regardless of whether the pump has been dropped or subjected to physical impacts.
• Always have backup insulin therapy available in your emergency preparedness kit.

Recall Justification (Not a Product Withdrawal) 

Medtronic is informing users of all MiniMed 600 and 700 series pumps about the heightened risk of reduced battery lifespan and a shorter time frame until the pump shuts down after receiving a battery alert. Pumps impacted by drops or other physical disruptions may have internal damage, affecting battery performance, sometimes even after a single drop. This issue could lead to the pump halting insulin delivery far sooner than expected.
 
This problem could have serious health implications, including elevated blood sugar (hyperglycemia), rapid fat breakdown in the body (diabetic ketoacidosis), and even fatality.

Between January 2023 and September 2024, Medtronic documented 170 instances of hyperglycemia over 400 mg/dL and 11 cases of diabetic ketoacidosis associated with these devices. Thankfully, there have been no reported deaths.

Device Functionality 

The MiniMed 600 and 700 series insulin pumps are portable, battery-operated devices that supply insulin for diabetes management in patients requiring insulin. They are also capable of receiving, storing, and displaying glucose levels from a transmitting unit.

Contact Details  

Patients in the United States can reach Medtronic at 1-800-378-2292 for round-the-clock technical assistance.

Complete List of Affected Models

Further FDA Resources  

Additional Company Information 

 
Unique Device Identifier (UDI) 

The Unique Device Identifier (UDI) provides a means to distinguish individual medical devices sold in the United States from the production stage through distribution and patient usage, allowing for improved reporting, reviewing, and analysis of adverse event data so that device-related issues can be identified and addressed more promptly. 

How to Report an Issue? 

Healthcare professionals and consumers can report adverse reactions or quality concerns they have experienced with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.