Agency classClass IIOur severity:High FDA (Devices)·Z-1359-2022·Announced 2022-07-20

MiniMed 780G Insulin Pump battery cap deterioration may cause power loss

Medtronic MiniMed is recalling 83,398 MiniMed 780G insulin pumps distributed throughout the United States due to battery cap deterioration that may cause power loss and device malfunction.

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: This is an FDA Class II recall with a potential power-loss hazard affecting insulin delivery. No illnesses, injuries, or deaths have been reported, and the hazard is described as potential. However, it poses a risk of harm to patients dependent on consistent insulin delivery, meeting the rubric criterion for High severity.

Plain-English summary

Medtronic MiniMed is recalling approximately 83,398 MiniMed 780G Insulin Pumps (O.U.S. Version) distributed throughout the United States. The recall was issued due to a potentially serious defect that may affect pump functionality.

The issue stems from battery cap deterioration, which may result in an incomplete battery circuit. This is similar to the circuit disruption that occurs when the battery cap is not fully attached. If this condition occurs, the pump may lose power and be unable to deliver insulin.

The affected devices can be identified by their serial number. All consumers currently using a MiniMed 780G pump should contact Medtronic MiniMed to determine whether their device is affected by this recall.

Consumers should not attempt to fix the device themselves. Instructions for addressing the recall should be obtained directly from the manufacturer.

The recalled product

Product: MiniMed 780G Insulin Pump (O.U.S. Version)
Manufacturer: Medtronic MiniMed
Category: Medical Device — Insulin Pump
Hazard: battery-deterioration
power-loss
Affected units: 83,398

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Product Number/CFN (O.U.S. Version) MiniMed 780G (MMT-1884
MMT-1885
MMT-1886
MMT-1894
MMT-1895

Distribution

Distributed in 53 states:

Part of a larger recall action

This product is one of 8 recalled by Medtronic MiniMed under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Medtronic MiniMed

See all →

High
Guardian Glucose Monitoring App May Automatically Log Out and Block Data Upload
FDA (Devices) · 2023-01-11
High
Insulin Pump Cybersecurity Vulnerability Allows Unauthorized Remote Access
FDA (Devices) · 2022-11-16
High
Medtronic MiniMed Insulin Pumps Recalled for Cybersecurity Vulnerability
FDA (Devices) · 2022-11-16
High
MiniMed 630G Insulin Pump Recalled for Battery Cap Deterioration
FDA (Devices) · 2022-07-20
High
MiniMed 620G insulin pump battery cap deterioration may cause power loss
FDA (Devices) · 2022-07-20

Same hazard · battery deterioration