Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life
This recall does not involve removing all products. Users should contact Medtronic if they experience significant reduced battery life to determine if a new pump is needed. The FDA has identified this recall as the most serious type.
Affected Product
- Product Names: MiniMed 630G, 670G, 770G, 780G
- Model: See full list of affected devices.
- Lot/Serial Numbers: All lots and serial numbers
Figure: MiniMed 670G insulin pump Figure: MiniMed 780G insulin pump
(MiniMed 630G and 670G pumps also affected but not pictured)
What to Do
- Replace the battery as soon as you receive the “Low Battery Pump” alert.
- Do not wait for later battery alerts, as these may occur when less battery life remains than noted in the User Guide.
- Carry extra batteries in case there is a need for an unexpected battery change.
- Contact Medtronic if there are any changes to battery life for your pump.
On July 31, 2024, Medtronic sent all affected customers a Safety Alert stating that users should follow their pump’s built in alerts and alarms battery status for the MiniMed 600 series and 700 series insulin pumps. If they observe changes in the battery life of their pump, to contact Medtronic.
On October 4, 2024, Medtronic issued an UPDATE: Urgent Medical Device Correction letter. The following actions were outlined in the October 2024 letter:
- Carry an extra set of new AA lithium or alkaline batteries or fully charged NiMH batteries in case a battery change is needed sooner than expected.
- Pay attention to all pump alerts and alarms.
- Replace the battery as soon as you receive the “Low Battery Pump” alert.
- Do not wait for later battery alerts, as these may occur when less battery life remains than noted in the User Guide.
- Refer to the User Guide for instructions on how to replace the battery.
- Be aware, when the “Replace Battery Now” alarm appears, insulin delivery stops.
- Contact Medtronic 24-Hour Technical Support team at 1-800-378-2292 to determine if a replacement pump is needed if the pump exhibits any significant decrease in battery life, whether or not the pump has been dropped, bumped, or experienced other physical impacts.
- Have back-up insulin therapy available at all times in your emergency kit.
Reason for Recall (Not a Product Removal)
Medtronic is notifying users of all MiniMed 600 and 700 series insulin pumps of an increased risk for reduced battery life and less time until shutdown after a battery alert occurs. Pumps that have been dropped, bumped, or experienced another physical impact may have damaged electrical components causing this issue—even a single drop can impact battery life. This may result in the pump stopping insulin delivery significantly sooner than usually expected.
The use of affected product may cause serious adverse health consequences, including high blood sugar (hyperglycemia), fat breaking down too fast in the body (diabetic ketoacidosis) and death.
From January 2023 to September 2024, Medtronic reports receiving 170 reports of hyperglycemia, >400mg/dL, and 11 reports of diabetic ketoacidosis related to this issue. There have been no reports of death.
Device Use
MiniMed 600 and 700 series insulin pumps are battery operated, portable pumps that deliver insulin for the management of diabetes in persons requiring insulin. These pumps also receive, store and display blood sugar (glucose) values from a transmitting device.
Contact Information
Customers in the U.S. can call Medtronic at 1-800-378-2292 for 24-hour technical support.
Full List of Affected Devices
| Models |
|---|
| MMT-1510 |
| MMT-1710 |
| MMT-1750 |
| MMT-1515 |
| MMT-1714 |
| MMT-1715 |
| MMT-1754 |
| MMT-1755 |
| MMT-1511 |
| MMT-1711 |
| MMT-1512 |
| MMT-1712 |
| MMT-1751 |
| MMT-1752 |
| MMT-1580 |
| MMT-1581 |
| MMT-1582 |
| MMT-1780 |
| MMT-1781 |
| MMT-1782 |
| MMT-1740 |
| MMT-1741 |
| MMT-1742 |
| MMT-1760 |
| MMT-1761 |
| MMT-1762 |
| MMT-1800 |
| MMT-1801 |
| MMT-1805 |
| MMT-1850 |
| MMT-1851 |
| MMT-1809 |
| MMT-1810 |
| MMT-1817 |
| MMT-1818 |
| MMT-1859 |
| MMT-1860 |
| MMT-1867 |
| MMT-1868 |
| MMT-1811 |
| MMT-1812 |
| MMT-1861 |
| MMT-1862 |
| MMT-1880 |
| MMT-1881 |
| MMT-1882 |
| MMT-1890 |
| MMT-1891 |
| MMT-1892 |
| MMT-1884 |
| MMT-1885 |
| MMT-1885 |
| MMT-1886 |
| MMT-1894 |
| MMT-1895 |
| MMT-1896 |
Additional FDA Resources
- FDA’s Enforcement Report
- Medical Device Recall Database
Additional Company Resources
- Voluntary Recall Notifying Medtronic Pump Users of Potential Risks of Shortened Pump Battery Life [10/4/2024]
- UPDATE: URGENT MEDICAL DEVICE CORRECTION [October 2024]
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.