Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM

FDA Device Recall #Z-1596-2020 — Class II — June 27, 2019

Recall Summary

Recall Number Z-1596-2020
Classification Class II — Moderate risk
Date Initiated June 27, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic MiniMed
Location Northridge, CA
Product Type Devices
Quantity 2,322

Product Description

Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM

Reason for Recall

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 unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Distribution Pattern

US nationwide distribution including Puerto Rico.

Lot / Code Information

All software versions 2.7A or lower. Available outside the US only.

Other Recalls from Medtronic MiniMed

Recall # Classification Product Date
Z-0776-2023 Class II Guardian iOS app (MMT-8200) and Guardian Androi... Nov 21, 2022
Z-0194-2023 Class II Insulin Pump/Model: MiniMed 620G/ MMT-1750 Mi... Sep 20, 2022
Z-0193-2023 Class II Insulin Pump/Model: MiniMed 630G/ MMT-1715, M... Sep 20, 2022
Z-1356-2022 Class II MiniMed 720G Insulin Pump (O.U.S. Version) May 23, 2022
Z-1357-2022 Class II MiniMed 740G Insulin Pump (O.U.S. Version) May 23, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.