Recall Z-2698-2026
Medtronic MiniMed, Inc. · initiated May 27, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Codes / lots: UDI-DI/GTIN: A7630006392701, 00763000521554, 00763000639273, A7630006392301, 00199150035687, A7630007325603, A7630007325601, 00763000639235, A7630007325604, 00763000384289, 00763000521530, A7630007325401, 00763000521547, A7630006392601, A7630006392201, 00763000639228, 00199150035663, 00763000639266, A7630007325404, 00199150035694, 00763000442194, A7630007325403, 00763000521523. Software version 6.62
Reason for recall
A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays 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).
FDA-determined cause: Software design
Action taken
On 5/27/2026, field safety notices were emailed to customers who were asked to do the following: 1) Update insulin pump software to version 6.63. The update may take up to 3 hours to complete. 2) Reply to this email to confirm that you have read and understood this notification and, where applicable, completed the required action. If you have questions, contact the firm at 01923 205167
Details
- Recall number
- Z-2698-2026
- Initiated
- May 27, 2026
- Posted by FDA
- July 8, 2026
- Product code
- QFG – Alternate Controller Enabled Insulin Infusion Pump
- Quantity
- 778
- Distribution
- International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
- Recalling firm
- Medtronic MiniMed, Inc., Northridge, CA