Health product recall

Reveal Linq Mobile Manager

Brand(s)
Last updated

Summary

Product
Reveal Linq Mobile Manager
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Reveal Linq Mobile Manager RLA223716G MSW002

Issue

The Reveal Linq Mobile Manager application (MSW002) versions 2.01, 2.02, 2.03.0, and 2.03.01. These versions of LMM have an updated insertion workflow that, if not followed properly, increases the likelihood the patient connector is removed from the device by users before the Reveal Linq device is programmed successfully.

This incomplete programming can result in the device's inability to detect and record some or all the following episode types: AT, AF, Tachy, Asystole, Brady, and patient-activated symptom episodes.

Recall start date: Mar 22, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies

Medtronic Inc.

8200 Coral Sea Street N.E., Mounds View, Minnesota

United States, 55112

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64063