CareLink SmartSync™ Applications
Brand(s)
Last updated
Summary
Product
CareLink SmartSync™ Applications
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| CareLink SmartSync™ Device Manager Application | All lots. | CARELINK SMARTSYNC DEVICE MANAGER APP |
| CareLink SmartSync™ Azure™ Astra™ Application | All lots. | D00U003 |
| CareLink SmartSync™ Cobalt™ Crome™ Application | All lots. | D00U005 |
| CareLink SmartSync™ Evera™ MRI Application | All lots. | D00U010 |
| CareLink SmartSync™ Micra™ AV Application | All lots. | D00U007 |
| CareLink SmartSync™ Viva™ Consulta™ Syncra™ Advisa™ Ensura™ Application | All lots. | D00U008 |
| CareLink SmartSync™ PSA Application | All lots. | D00U002 |
| CareLink SmartSync™ VisiaAF™ Application | All lots. | D00U011 |
| CareLink SmartSync™ Viva™ Brava™ Evera™ Application | All lots. | D00U012 |
| CareLink SmartSync™ Micra™ VR Application | All lots. | D00U006 |
| CareLink SmartSync™ Micra™ VR2 Application | All lots. | D00U022 |
| CareLink SmartSync™ Micra™ VR2 Application | All lots. | D00U009 |
| CareLink SmartSync™ Micra™ AV2 Application | All lots. | D00U022 |
| CareLink SmartSync™ Percepta™ Serena™ Solara™ Application | All lots. | D00U004 |
Issue
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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - Cardiovascular
Companies
Medtronic Inc.
710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77646
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