MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Summary
The FDA issued a Class II for MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 by Medtronic MiniMed, Inc.. Reason: A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering ins.
Details
Source
Device Recall
External ID
Z-2698-2026
Action Date
2026-07-15
Status
Ongoing
Category
device
Product Description
MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Lot/Code Info: 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
Quantity Affected: 778
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).
Distribution
International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-27
Company
Northridge, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 143 device recalls issued in the same week, part of 452 device-related FDA actions this month.
Medtronic MiniMed, Inc. has 44 FDA actions in our database, including 38 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic MiniMed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic MiniMed, Inc. have FDA actions?
Medtronic MiniMed, Inc. has 44 FDA actions in our database, including 38 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2698-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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