Medical devicesUpdated Jan 3, 2026MEDTRONIC INC.Official source

    CareLink SmartSync™ Applications recall in Canada: performance issues

    Share:

    In plain language

    This recall involves various CareLink SmartSync™ Applications sold in Canada. They are being recalled because of performance issues that can lead to incorrect messages being displayed. Contact the manufacturer for more information.

    What to do

    • Contact the manufacturer if you require additional information.

    Get alerts for recalls like this

    Get email alerts when new recalls affect products in this category.

    Categories (optional)

    No spam. Unsubscribe anytime. We only email when there's a relevant recall.

    Affected products

    • CareLink SmartSync™ Device Manager Application

      Model: CARELINK SMARTSYNC DEVICE MANAGER APP

      Lot: All lots

    • CareLink SmartSync™ Azure™ Astra™ Application

      Model: D00U003

      Lot: All lots

    • CareLink SmartSync™ Cobalt™ Crome™ Application

      Model: D00U005

      Lot: All lots

    • CareLink SmartSync™ Evera™ MRI Application

      Model: D00U010

      Lot: All lots

    • CareLink SmartSync™ Micra™ AV Application

      Model: D00U007

      Lot: All lots

    • CareLink SmartSync™ Viva™ Consulta™ Syncra™ Advisa™ Ensura™ Application

      Model: D00U008

      Lot: All lots

    • CareLink SmartSync™ PSA Application

      Model: D00U002

      Lot: All lots

    • CareLink SmartSync™ VisiaAF™ Application

      Model: D00U011

      Lot: All lots

    • CareLink SmartSync™ Viva™ Brava™ Evera™ Application

      Model: D00U012

      Lot: All lots

    • CareLink SmartSync™ Micra™ VR Application

      Model: D00U006

      Lot: All lots

    • CareLink SmartSync™ Micra™ VR2 Application

      Model: D00U009, D00U022

      Lot: All lots

    • CareLink SmartSync™ Micra™ AV2 Application

      Model: D00U022

      Lot: All lots

    • CareLink SmartSync™ Percepta™ Serena™ Solara™ Application

      Model: D00U004

      Lot: All lots

    Do I have this product?

    This recall only applies to specific products. Follow the steps below to check.

    1. 1

      Check the product name

      Make sure your product name matches one of the affected products listed above.

    2. 2

      Check the lot number

      Lot numbers identify specific production batches.

      Affected lots: All lots

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: CARELINK SMARTSYNC DEVICE MANAGER APP, D00U002, D00U003, D00U004, D00U005, D00U006, D00U007, D00U008, D00U009, D00U010, D00U011, D00U012, D00U022

    If your product matches one or more of the details above, it may be affected by this recall.

    If your product does not match these details, it is not affected by this recall.

    When in doubt, always check the official notice.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    This recall involves various CareLink SmartSync™ Applications sold in Canada. They are being recalled because of performance issues that can lead to incorrect messages being displayed. Contact the manufacturer for more information.

    What should consumers do?

    Contact the manufacturer if you require additional information.

    Where was the product sold?

    This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.

    Is there a health risk?

    A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.

    When was this product recalled?

    This product was recalled on June 25, 2025.

    Is the MEDTRONIC INC. brand affected by this recall?

    Yes, MEDTRONIC INC. products are affected by this recall. This recall involves various CareLink SmartSync™ Applications sold in Canada. They are being recalled because of performance issues that can lead to incorrect messages being displayed. Contact the manufacturer for more information.