The Recall Desk
SevereFDA (Devices)·Z-1589-2020·Announced 2020-04-01

Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerabilities

Medtronic MiniMed is recalling 38 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While no injuries are explicitly reported in the text, the potential for unauthorized control of a life-sustaining medical device (insulin pump) represents a significant risk of harm, aligning with the Severe classification for high-risk medical devices.

Plain-English summary

Medtronic MiniMed is recalling 38 units of the MiniMed Paradigm Insulin pump, model number MMT-522K, across all software versions. The recall covers units distributed nationwide in the United States, including Puerto Rico.

The recall is 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 with this specific model should contact Medtronic MiniMed for instructions on how to proceed with the recall.

The recalled product

Product
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
Manufacturer
Medtronic MiniMed
Category
Medical Device — Insulin Pump
Hazard
Affected units
38

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

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 →

Related recalls

Same manufacturer · Medtronic MiniMed

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Same hazard · cybersecurity vulnerability

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