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Recall Observatory FDA recall evidence

Device product

Medtronic MiniMed Paradigm Insulin pump, model number MMT-722

Z-1588-2020

June 27, 2019

Class II

Product summary

Firm
Medtronic MiniMed
Event
Event 83433
Status
Ongoing
Classification
Class II
Quantity
225,498
Official record key
device-enforcement:Z-1588-2020

Official wording

Reason: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.

Code information: All software Versions

Distribution pattern: US nationwide distribution including Puerto Rico.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    cybersecurity vulnerabilities