The Recall Desk
HighFDA (Devices)·Z-0194-2023·Announced 2022-11-16

Insulin Pump Cybersecurity Vulnerability Allows Unauthorized Remote Access

MiniMed 600 series insulin pumps have a cybersecurity vulnerability that could allow unauthorized access, potentially resulting in delivery of too much or too little insulin. Users should disable the Remote Bolus feature.

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: This FDA Class II medical device recall involves a cybersecurity vulnerability that could lead to improper insulin dosing with serious health consequences. No illnesses or injuries have been reported. Per the severity rubric, a risk-of-harm product without reported injury scores at most 3 (High).

Plain-English summary

Medtronic has identified a cybersecurity vulnerability in MiniMed 600 series insulin pumps (models 620G and 640G). The vulnerability exists in the communication protocol used by these devices. Approximately 316,326 units have been distributed across the United States, U.S. territories, and multiple countries worldwide.

This vulnerability could allow unauthorized access to the insulin pump system. An unauthorized party could use this access to deliver too much or too little insulin by triggering an unintended insulin bolus or by slowing or stopping insulin delivery. Such unintended delivery could lead to dangerously high blood sugar (hyperglycemia) or dangerously low blood sugar (hypoglycemia).

Users of affected MiniMed 600 series insulin pumps should immediately disable the Remote Bolus feature to prevent unauthorized access to their device.

The recalled product

Product
Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
Manufacturer
Medtronic MiniMed
Category
Medical Device — Insulin Pump
Hazard
Affected units
316,326

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 (20)

  • Model/UDI-GTIN (All Serial Numbers): MMT-1750/00763000375461
  • 00643169559745
  • MMT-1711/643169554931
  • 763000367039
  • 00643169890039
  • 00643169554917
  • 00643169629813
  • 00643169554924
  • 00643169554931
  • 00643169742062
  • 00763000013066
  • 00643169554948
  • 00643169554955
  • 00643169621954
  • MMT-1712/643169662612
  • 643169577701
  • 00763000205409
  • 00643169890046
  • 00643169577664
  • 00643169629820

Distribution

Distributed in 54 states:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

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Same hazard · cybersecurity vulnerability

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