Health product recall

Paradigm Insulin Infusion pumps Remote programmer

Last updated

Summary

Product
Paradigm Insulin Infusion pumps Remote programmer
Issue
Medical devices - Performance issue
What to do
Immediately stop using the product and contact manufacturer. 

Affected products

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number:

MMT-503

MMT-503NA

Issue

In May 2018, an external cybersecurity researcher identified a potential risk related to the MiniMed Paradigm Family of insulin pumps and corresponding remote controller. The researcher's report stated that an unauthorized individual in close proximity to an insulin pump user could potentially copy the wireless RF signals from the user's remote controller (for example, while the user is in the process of delivering a remote Bolus) and play those back later to deliver an involuntary Bolus of insulin to the pump user. This could lead to potential health risks such as Hypoglycemia if additional insulin is delivered beyond the user's insulin requirements, or
Hyperglycemia if insulin delivery is suspended. To date, Medtronic has not received any reports of injuries resulting from this issue. Medtronic has determined that the potential risks associated with the Minimed Remote controller outweigh the benefits of its continued use. Therefore, manufacturer is providing updated instructions to further address this risk. Customers should immediately stop using and disconnect the remote controller, disable the remote feature, and return the remote controller to Medtronic.

 

Recall start date: October 5, 2021

What you should do

Immediately stop using the product and contact manufacturer. 

Additional information

Details
Original published date: 2021-10-28
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

Medtronic Minimed

18000 Devonshire St.

Northridge

91325

California

UNITED STATES

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-62936