Medtronic MiniMed and Paradigm Insulin Pumps Recalled for Delivery Errors

Agency Publication Date: March 3, 2025

Summary

Medtronic MiniMed, Inc. has recalled approximately 912,119 insulin pumps, including the Paradigm series, MiniMed 530G, 600 series, and 700 series. These devices were found to potentially deliver incorrect doses of insulin during air travel due to changes in air pressure during airplane take-off and landing. Laboratory testing revealed that pressure changes can cause the devices to deliver about 0.569 units too much insulin during take-off or about 0.537 units too little insulin during landing, regardless of the pump's programmed delivery rate.

Risk

Incorrect insulin delivery can cause life-threatening health issues. Over-delivery of insulin can lead to severe hypoglycemia, seizures, coma, or death, while under-delivery can cause severe hyperglycemia, dehydration, or diabetic ketoacidosis.

What You Should Do

This recall affects Medtronic MiniMed insulin pumps from the Paradigm, 530G, 600 series, and 700 series product lines, used by patients to manage diabetes.
Check your insulin pump to see if it is one of the affected models, such as the 630G, 670G, 770G, or 780G. You can find the model and REF numbers printed on the back of your device. See the Affected Products section below for the full list of affected codes.
Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Medtronic for further instructions.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement

Option 2: Dispose of Product

How to: Stop using and throw the product away.

Affected Products

Product: Paradigm Insulin Pump (MMT-712, MMT-715)

Model / REF:

MMT-712

MMT-715

UDI:

All UDI numbers

All Lot Numbers affected.

Product: Paradigm Insulin Pump (MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751)

Model / REF:

MMT-522

MMT-523

MMT-551

MMT-722

MMT-723

MMT-751

UDI:

All UDI numbers

All Lot Numbers affected.

Product: Paradigm Insulin Pump (MMT-754)

Model / REF:

MMT-754

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (620G)

Model / REF:

MMT-1750

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (630G)

Model / REF:

MMT-1714

MMT-1715

MMT-1754

MMT-1755

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (640G)

Model / REF:

MMT-1711

MMT-1712

MMT-1751

MMT-1752

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (670G)

Model / REF:

MMT-1760

MMT-1761

MMT-1762

MMT-1780

MMT-1781

MMT-1782

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (700G)

Model / REF:

MMT-1801

MMT-1805

MMT-1850

MMT-1851

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (720G)

Model / REF:

MMT-1809

MMT-1810

MMT-1859

MMT-1860

MMT-1867

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (740G)

Model / REF:

MMT-1811

MMT-1812

MMT-1861

MMT-1862

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (770G)

Model / REF:

MMT-1880

MMT-1881

MMT-1882

MMT-1890

MMT-1891

MMT-1892

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (780G)

Model / REF:

MMT-1884

MMT-1885

MMT-1886

MMT-1894

MMT-1895

MMT-1896

UDI:

All UDI numbers

All Lot Numbers affected.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96200

Status: Active

Manufacturer: Medtronic MiniMed, Inc.

Sold By: Authorized Medtronic distributors; Healthcare providers; Medtronic MiniMed, Inc.

Manufactured In: United States

Units Affected: 12 products (20,760 units; 46,437 units; 41,404 units; 228 units; 70587 units; 168,240; 100,074 units; 4,959 unit; 8,677; 15,439 units; 106,289 units; 329,025 units)

Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, U.S. Virgin Islands, Vermont, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Medtronic MiniMed insulin pumps from the Paradigm, 530G, 600 series, and 700 series product lines, used by patients to manage diabetes.

Check your insulin pump to see if it is one of the affected models, such as the 630G, 670G, 770G, or 780G. You can find the model and REF numbers printed on the back of your device. See the Affected Products section below for the full list of affected codes.

Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or Medtronic for further instructions.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Affected Products

Product: Paradigm Insulin Pump (MMT-712, MMT-715)

Model / REF:

MMT-712

MMT-715

UDI:

All UDI numbers

All Lot Numbers affected.

Product: Paradigm Insulin Pump (MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751)

Model / REF:

MMT-522

MMT-523

MMT-551

MMT-722

MMT-723

MMT-751

UDI:

All UDI numbers

All Lot Numbers affected.

Product: Paradigm Insulin Pump (MMT-754)

Model / REF:

MMT-754

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (620G)

Model / REF:

MMT-1750

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (630G)

Model / REF:

MMT-1714

MMT-1715

MMT-1754

MMT-1755

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (640G)

Model / REF:

MMT-1711

MMT-1712

MMT-1751

MMT-1752

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (670G)

Model / REF:

MMT-1760

MMT-1761

MMT-1762

MMT-1780

MMT-1781

MMT-1782

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (700G)

Model / REF:

MMT-1801

MMT-1805

MMT-1850

MMT-1851

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (720G)

Model / REF:

MMT-1809

MMT-1810

MMT-1859

MMT-1860

MMT-1867

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (740G)

Model / REF:

MMT-1811

MMT-1812

MMT-1861

MMT-1862

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (770G)

Model / REF:

MMT-1880

MMT-1881

MMT-1882

MMT-1890

MMT-1891

MMT-1892

UDI:

All UDI numbers

All Lot Numbers affected.

Product: MiniMed Insulin Pump (780G)

Model / REF:

MMT-1884

MMT-1885

MMT-1886

MMT-1894

MMT-1895

MMT-1896

UDI:

All UDI numbers

All Lot Numbers affected.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96200

Status: Active

Manufacturer: Medtronic MiniMed, Inc.

Sold By: Authorized Medtronic distributors; Healthcare providers; Medtronic MiniMed, Inc.

Manufactured In: United States

Units Affected: 12 products (20,760 units; 46,437 units; 41,404 units; 228 units; 70587 units; 168,240; 100,074 units; 4,959 unit; 8,677; 15,439 units; 106,289 units; 329,025 units)