# K053177: Medtronic Minimed Paradigm Insulin Pump, Model MMT-712E

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Jan 31, 2006 after 78 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medtronic MiniMed Paradigm Model MMT-712 Insulin Pump: named in the summary without a submission number

## Recalls of this device
- Feb 13, 2026 · Class II · Z-1748-2026: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered 
- Jan 31, 2025 · Class II · Z-1255-2025: All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be foun
- Jun 27, 2019 · Class II · Z-1585-2020: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorize
- Apr 27, 2007 · Not classified · Z-1007-2007: Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were

## Indications for use
The Medtronic MiniMed Paradigm Model 712E Insulin Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Source page: https://510kreport.com/device/K053177
Methodology: https://510kreport.com/methodology