FDA recall, , Moderate risk
MiniMed 780G Insulin Pump
The MiniMed 780G Insulin Pump can stop delivering insulin due to a software anomaly, leading to delayed therapy and increased risk of hyperglycemia or DKA.
Summary by Recall Canary from the FDA notice
What happened
Medtronic MiniMed, Inc., of Northridge, California, began a recall on May 27, 2026, of the MiniMed 780G Insulin Pump, which the FDA added to its Enforcement Report on July 8, 2026.
The recall was initiated because a software anomaly can occur when the pump is paired with the Instinct sensor, causing the pump to unexpectedly stop delivering insulin and display two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or diabetic ketoacidosis (DKA).
The product was distributed internationally to Spain, Great Britain, Netherlands, and Italy.
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?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
- UDI-DI
- 00763000521554
- 00763000639273
- 00199150035687
- 00763000639235
- 00763000384289
- 00763000521530
- 00763000521547
- 00763000639228
- 00199150035663
- 00763000639266
- 00199150035694
- 00763000442194
- 00763000521523
Recall details
- Company began the recall
- Sold in
International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
- 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
- 99207
- Recall number
- Z-2698-2026
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
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
