The Recall Desk
HighFDA (Devices)·Z-1585-2020·Announced 2020-04-01

Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerability

Medtronic MiniMed is recalling 36,143 Paradigm insulin pumps due to a cybersecurity vulnerability 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 risk-of-harm product (insulin pump) where unauthorized control could lead to injury, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.

Plain-English summary

Medtronic MiniMed is recalling 36,143 units of the MiniMed Paradigm Insulin pump, model number MMT-712E. The recall was initiated due to potential cybersecurity vulnerabilities related to the device's wireless radio frequency (RF) communication capabilities.

The hazard involves the possibility that an unauthorized person could connect wirelessly to a nearby insulin pump to change settings and control insulin delivery. The affected units were distributed nationwide in the United States, including Puerto Rico. The source text notes that all software versions available outside the US are affected.

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

The recalled product

Product
Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
Manufacturer
Medtronic MiniMed
Category
Medical Device — Insulin Pump
Hazard
Affected units
36,143

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 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 →

Related recalls

Same manufacturer · Medtronic MiniMed

See all →

Same hazard · cybersecurity vulnerability

See all →