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

Source: FDA · Worldwide

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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 this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 6, 2026 and geographically references Worldwide. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.

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.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.