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Medtronic MiniMed Paradigm Insulin pump, model number… recallZ-1593-2020 · Medtronic MiniMed · initiated Jun 27, 2019

Class II Open, Classified All recalls posted in March 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic MiniMed or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1593-2020
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jun 27, 2019
Posted by the FDA
Mar 26, 2020
Recalling firm
Medtronic MiniMed
Quantity
10
Product code
OYC
FDA submissions
P980022
Distribution
US nationwide distribution including Puerto Rico.

Product description

Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K

Code information (models, lots, serial numbers)

All software versions 2.4A or lower

Other devices under the same FDA submission

277 devices cleared under P980022 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 83433).

Sources and updates

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