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The official notice did not include a photo. Check the product details and identifiers below.
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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
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
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
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Turn on recall alertsAffected products
Affected products
Product 1
Product 2
Product 3
Product 4
Product 5
Product 6
Product 7
Product 8
Product 9
Product 10
Product 11
Product 12
Product 13
Product 14
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Medtronic, Carelink Smartsync™ Applications.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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