The Recall Desk
HighFDA (Devices)·Z-1584-2020·Announced 2020-04-01

Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerability

Medtronic MiniMed is recalling 74,496 MiniMed 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 without reported injury.

Plain-English summary

Medtronic MiniMed is recalling 74,496 MiniMed Paradigm Insulin pumps, model number MMT-712, across all software versions. The recall was initiated due to potential cybersecurity vulnerabilities related to the pumps' wireless radio frequency (RF) communication capabilities.

The hazard involves the potential for an unauthorized person to connect wirelessly to a nearby insulin pump. If successful, this connection could allow the unauthorized person to change settings and control insulin delivery. The affected units were distributed nationwide in the United States, including Puerto Rico.

Consumers with this specific model of insulin pump 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
MiniMed Paradigm Insulin pump, model number MMT-712
Manufacturer
Medtronic MiniMed
Category
Medical Device — Insulin Pump
Hazard
Affected units
74,496

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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