Z-1591-2020Class II

Medtronic MiniMed Paradigm Insulin pump, model number MMT-523

Name: Z-1591-2020 Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
Creator: Medtronic MiniMed
Published: 2019-06-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-06-27 / Open, Classified / root cause: design

FDA source

Medtronic MiniMed began a recall of Medtronic MiniMed Paradigm Insulin pump, model number MMT-523 on 2019-06-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1591-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-06-27
Posted: 2020-03-26
Recalling firm: Medtronic, Inc.
Product: Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
Product code: OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
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.
Root cause tag: design
FDA root cause: Device Design
Action: On June 27, 2019, Medtronic issued an Urgent Field Safety Notification letter via mail and email to its consignees. Medtronic made the decision to renotify customers, and on January 4, 2023, Medtronic issued an Urgent Medical Device Correction - Update letter. The communication asks consignees to take the following actions: .To find the software version for the MiniMed Paradigm pumps, go to the STATUS screen: . To open the STATUS screen, press ESC until the STATUS screen appears. . To view more text on the STATUS screen, press the up or down arrow to scroll and view all the information. . To exit the STATUS screen, press ESC until the STATUS screen disappears. ACTIONS REQUIRED: 1. Review and take the following cybersecurity precautions listed below. 2. Please complete and sign the customer confirmation form attached as indicated and return by mail using the attached prepaid envelope. You can also email this form to our Field Corrective Action Department at [email protected] or send via fax to 1-888-844-8084 to the attention of FCA Department.
Quantity in commerce: 23,221
Distribution: US nationwide distribution including Puerto Rico.
Product codes and lots: All software versions 2.4A or lower

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1591-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1581-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1582-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1583-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1584-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1585-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1586-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1587-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1588-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1589-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1590-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1591-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1592-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1593-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1594-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1595-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26
Z-1596-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-04-01	2020-03-26

Product code OYC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)