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Reveal linq mobile manager

Official notice

11 Apr 2022

Last checked

11 Apr 2022

Medium riskHealth Canada

An official Health Canada notice concerns Reveal linq mobile manager. 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 Published 2022-04-11.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64063

Official notice

2022-04-11

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64063

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Affected products

Product 1

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

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic, Reveal Linq Mobile Manager.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

64063

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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