The Recall Desk
HighFDA (Devices)·Z-1594-2020·Announced 2020-04-01

Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

Medtronic MiniMed is recalling 72,850 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (insulin pump) where unauthorized control could lead to harm, but the source text does not report any actual injuries, illnesses, or deaths, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic MiniMed is recalling 72,850 units of the MiniMed Paradigm Insulin Pump, model number MMT-723. The recall covers all software versions 2.4A or lower. These devices were distributed nationwide in the United States, including Puerto Rico.

The recall is being initiated due to potential cybersecurity vulnerabilities related to the pumps' wireless radio frequency (RF) communication capabilities. An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Consumers using these specific insulin pumps should contact Medtronic MiniMed for instructions on how to proceed. The source text does not specify a particular action for consumers other than the initiation of the recall action.

The recalled product

Product
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
Manufacturer
Medtronic MiniMed
Affected units
72,850

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All software versions 2.4A or lower

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 16 recalled by Medtronic MiniMed under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →