The Recall Desk
HighFDA (Devices)·Z-1595-2020·Announced 2020-04-01

Medtronic MiniMed Paradigm Veo Insulin Pumps Recalled for Cybersecurity Vulnerabilities

Medtronic MiniMed is recalling Paradigm Veo 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 serious harm, but the source text does not report any actual injuries, illnesses, or unauthorized access incidents, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Medtronic MiniMed is recalling 68,598 units of the MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754. The recall covers all software versions 2.6A 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. The source text does not report any specific incidents of unauthorized access or patient harm.

Consumers should contact Medtronic MiniMed for instructions on how to address the cybersecurity vulnerabilities. The recall is classified as Class II by the FDA.

The recalled product

Product
Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
Manufacturer
Medtronic MiniMed
Affected units
68,598

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 2.6A or lower. Available outside the US only.

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 →