FDA recall Z-2698-2026

Medtronic MiniMed, Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2026-05-27
Report date
2026-07-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northridge, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2698-2026