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Health Canada Medical devices

Reveal Linq Mobile Manager

Issued April 11, 2022
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
Hazard description
Software defect
Product
Product name
Reveal Linq Mobile Manager
Reference
ID
RA-64063