Recall Z-1584-2020— Medtronic MiniMed

Name: FDA recall Z-1584-2020
Creator: U.S. Food and Drug Administration
Published: 2019-06-27

Class II · Ongoing

Class II FDA medical device recall by Medtronic MiniMed, initiated 2019-06-27. It names one FDA 510(k) clearance: K120206. Product: MiniMed Paradigm Insulin pump, model number MMT-712. 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..

Recalling firm: Medtronic MiniMed
Classification: Class II
Status: Ongoing
Initiated: 2019-06-27
Firm location: Northridge, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K120206 — MEDTRONIC MINIMED PARADIGM INSULIN PUMPSMedtronic Minimed·cleared 2012-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MiniMed Paradigm Insulin pump, model number MMT-712

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.