RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026EMBLEMOfficial source

    EMBLEM S-ICD Subcutaneous Electrode recall in Canada: fracture risk

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    In plain language

    This recall involves the EMBLEM S-ICD Subcutaneous Electrode sold in Canada. It's being recalled because the electrode may fracture. Stop using the product and follow the return steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check model and lot numbers.
    • Return the affected electrodes as instructed.

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    Affected products

    • EMBLEM S-ICD Subcutaneous Electrode

      Model: 3501

      Lot: 643501-700

    Why this matters

    Fracture risk

    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: 643501-700

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 3501

    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?

    Fracture risk

    What should consumers do?

    Stop using the product immediately. Check model and lot numbers. Return the affected electrodes as instructed.

    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?

    Yes, there may be a health risk. Fracture risk

    When was this product recalled?

    This product was recalled on October 15, 2021.

    Is the EMBLEM brand affected by this recall?

    Yes, EMBLEM products are affected by this recall. This recall involves the EMBLEM S-ICD Subcutaneous Electrode sold in Canada. It's being recalled because the electrode may fracture. Stop using the product and follow the return steps in the official notice.