The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1238-2026·Announced 2026-02-11

Insulin pumps recalled over errors that suspend insulin delivery

Medtronic MiniMed is recalling 577 MiniMed 780G insulin pumps on software version 6.60 because a timing and processor communication issue may trigger Pump Error 43 or 41, suspending insulin delivery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the fault results in suspension of insulin delivery, and no injuries are reported.

Plain-English summary

The MiniMed 780G Insulin Pump, catalog numbers MMT-1884 and MMT-1886, with software version 6.60, is being recalled by Medtronic MiniMed, Inc. The record states the pump is indicated for use by patients aged 7-80 years with Type 1 diabetes whose total daily dose of insulin is 8 units per day or more, and that the system is intended for continuous delivery of basal insulin at selectable rates and administration of insulin boluses.

The reason given in the enforcement record is a software timing and processor communication issue in MiniMed 780G software version 6.60 that may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.

The record lists 577 units, with UDI-DI codes recorded in the enforcement record. Distribution was worldwide, including national distribution in the United States across the states listed in the record. The FDA has classified the action as Class II.

A suspension of insulin delivery leaves a person with type 1 diabetes without their basal insulin until it is restored. The enforcement record reports no injuries. Users should follow Medtronic's instructions and know how to respond to a pump error.

The recalled product

Product
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system…
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin pump
Hazard
Affected units
577

Distribution

Distributed in 45 states:

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