Z-2698-2026Class II

MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896

Name: Z-2698-2026 MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Creator: Medtronic MiniMed, Inc.
Published: 2026-05-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2026-05-27 / Open, Classified / root cause: software

FDA source

Medtronic MiniMed, Inc. began a recall of MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 on 2026-05-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2698-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-27
Posted: 2026-07-08
Recalling firm: Medtronic, Inc.
Product: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Product code: QFG Alternate Controller Enabled Insulin Infusion Pump
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).
Root cause tag: software
FDA root cause: Software design
Action: 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
Quantity in commerce: 778
Distribution: International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2698-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2698-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-15	2026-07-08

Product code QFG

K251032Class IIMiniMed 780G insulin pumpMedtronic Minimed, Inc. / cleared 2025-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)