Medtronic Recalls MiniMed 780G Insulin Pumps Due to Software Error Suspending Insulin Delivery

FDA Recalls high FDA · · Worldwide

Medtronic MiniMed, Inc. has recalled 577 MiniMed 780G insulin pumps because a software timing issue may trigger errors that stop insulin delivery, posing a health risk to patients.

What Happened

Medtronic MiniMed, Inc. has initiated a voluntary recall of specific MiniMed 780G insulin pumps due to a software timing and processor communication issue. In devices running software version 6.60, this technical glitch may trigger “Pump Error 43” or “Pump Error 41.” When these errors occur, the device may unexpectedly suspend insulin delivery.

Which Products Are Affected

The recall affects 577 units of the MiniMed 780G Insulin Pump with Software Version 6.60. The following catalog numbers and UDI-DI codes are included:

  • MiniMed 780G Catalog MMT-1884 (United States): UDI-DI codes include 00199150003686, 00763000414344, 00763000545604, 00763000578640, 00763000586195, 00763000640095, 00763000758547, 00763000819378, 00763000819385, 00763000819392, 00763000865665, 00763000924089, 00763000924102, 00763000924119, 76300075854701, 76300081937801, 76300081938501, 76300096001801, 76300096003201, and 76300096004901.
  • MiniMed 780G Catalog MMT-1886 (Israel): UDI-DI code 76300062988501.

Distribution in the United States includes the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Hundreds of specific serial numbers are affected across these regions.

What You Should Do

Medtronic MiniMed, Inc. began notifying affected customers via letter on November 2, 2025. Consumers using a MiniMed 780G pump should check their software version and catalog number. If you are using an affected device, follow the specific instructions provided in the notification letter from Medtronic. If the device displays Pump Error 41 or 43, be aware that insulin delivery has been suspended and immediate action may be required to manage glucose levels.

Why This Matters

The MiniMed 780G system is used by patients with Type 1 diabetes for the continuous delivery of basal insulin. A sudden suspension of insulin delivery can lead to serious health complications, including hyperglycemia and diabetic ketoacidosis.

Source

This recall is classified as a Class II recall by the FDA under recall number Z-1238-2026.

Source: FDA Official Notice