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Carelink smartsync™ applications

Official notice

25 Jun 2025

Last checked

25 Jun 2025

Critical riskHealth Canada
Watch Medtronic

An official Health Canada notice concerns Carelink smartsync™ applications. This recall pertains to a device electrical reset message being displayed inappropriately (i.e., when a true device electrical reset did not occur). There are two issues when the device electrical reset message is displayed inappropriately: Issue #1: The user is informed there was a device electrical reset when there was not. This can cause confusion and might lead the user to believe the device is no longer functioning properly. Issue #2: One of the messages that can be displayed inappropriately recommends device explant ("serious device error: device should be explanted"). While the message may be factually correct for the type of electrical reset it is designed to indicate, if displayed inappropriately it increases the risk of explant and patient harm. Recall start date: June 18, 2025 Published 2025-06-25.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77646

Official notice

2025-06-25

The hazard

This recall pertains to a device electrical reset message being displayed inappropriately (i.e., when a true device electrical reset did not occur). There are two issues when the device electrical reset message is displayed inappropriately: Issue #1: The user is informed there was a device electrical reset when there was not. This can cause confusion and might lead the user to believe the device is no longer functioning properly. Issue #2: One of the messages that can be displayed inappropriately recommends device explant ("serious device error: device should be explanted"). While the message may be factually correct for the type of electrical reset it is designed to indicate, if displayed inappropriately it increases the risk of explant and patient harm. Recall start date: June 18, 2025

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

77646

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Affected products

Product 1

Affected products - CareLink SmartSync™ Device Manager Application, Lot or serial number - All lots., Model or catalog number - CARELINK SMARTSYNC DEVICE MANAGER APP

Product 2

Affected products - CareLink SmartSync™ Azure™ Astra™ Application, Lot or serial number - All lots., Model or catalog number - D00U003

Product 3

Affected products - CareLink SmartSync™ Cobalt™ Crome™ Application, Lot or serial number - All lots., Model or catalog number - D00U005

Product 4

Affected products - CareLink SmartSync™ Evera™ MRI Application, Lot or serial number - All lots., Model or catalog number - D00U010

Product 5

Affected products - CareLink SmartSync™ Micra™ AV Application, Lot or serial number - All lots., Model or catalog number - D00U007

Product 6

Affected products - CareLink SmartSync™ Viva™ Consulta™ Syncra™ Advisa™ Ensura™ Application, Lot or serial number - All lots., Model or catalog number - D00U008

Product 7

Affected products - CareLink SmartSync™ PSA Application, Lot or serial number - All lots., Model or catalog number - D00U002

Product 8

Affected products - CareLink SmartSync™ VisiaAF™ Application, Lot or serial number - All lots., Model or catalog number - D00U011

Product 9

Affected products - CareLink SmartSync™ Viva™ Brava™ Evera™ Application, Lot or serial number - All lots., Model or catalog number - D00U012

Product 10

Affected products - CareLink SmartSync™ Micra™ VR Application, Lot or serial number - All lots., Model or catalog number - D00U006

Product 11

Affected products - CareLink SmartSync™ Micra™ VR2 Application, Lot or serial number - All lots., Model or catalog number - D00U022

Product 12

Affected products - CareLink SmartSync™ Micra™ VR2 Application, Lot or serial number - All lots., Model or catalog number - D00U009

Product 13

Affected products - CareLink SmartSync™ Micra™ AV2 Application, Lot or serial number - All lots., Model or catalog number - D00U022

Product 14

Affected products - CareLink SmartSync™ Percepta™ Serena™ Solara™ Application, Lot or serial number - All lots., Model or catalog number - D00U004

Risk / hazard

This recall pertains to a device electrical reset message being displayed inappropriately (i.e., when a true device electrical reset did not occur). There are two issues when the device electrical reset message is displayed inappropriately: Issue #1: The user is informed there was a device electrical reset when there was not. This can cause confusion and might lead the user to believe the device is no longer functioning properly. Issue #2: One of the messages that can be displayed inappropriately recommends device explant ("serious device error: device should be explanted"). While the message may be factually correct for the type of electrical reset it is designed to indicate, if displayed inappropriately it increases the risk of explant and patient harm. Recall start date: June 18, 2025

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Medtronic, Carelink Smartsync™ Applications

Manufacturer

Not provided

Phone

Not provided

Brand: Medtronic, Carelink Smartsync™ Applications.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

77646

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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