FDA recall, , Moderate risk
Medtronic MiniMed 780G Insulin Pump
A software issue may cause Pump Error 43 or 41, suspending insulin delivery.
Summary by Recall Canary from the FDA notice
What happened
Medtronic MiniMed, Inc. of Northridge, California is recalling 577 units of the MiniMed 780G Insulin Pump with Software Version 6.60. A software timing and processor communication issue may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery. The pump is indicated for patients age 7-80 years with Type 1 diabetes.
The company began the recall on November 2, 2025, and the FDA added it to the Enforcement Report on February 2, 2026. The product was distributed worldwide, including U.S. national distribution across many states and the country of Israel.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
MiniMed 780G Insulin Pump Catalog Numbers
- UDI-DI
- 00199150003686
- 00763000414344
- 00763000545604
- 00763000578640
- 00763000586195
- 00763000640095
- 00763000758547
- 00763000819378
- 00763000819385
- 00763000819392
- 00763000865665
- 00763000924089
- 00763000924102
- 00763000924119
- 76300075854701
- 76300081937801
- 76300081938501
- 76300096001801
- 76300096003201
- 76300096004901
- 76300062988501
From the FDA notice
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more.
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. National distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and West Virginia. The country of Israel.
- Company
- Medtronic MiniMed, Inc.Northridge, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97997
- Recall number
- Z-1238-2026
- Quantity recalled
- 577 units
All recalls from Medtronic MiniMed, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary