RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Official source

    nGEN Generators recall in Canada: char complaints

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    In plain language

    This recall involves nGEN Generators in Canada. It's being recalled because of a higher than expected number of "char" complaints when used with the QDOT Ablation Catheter. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Check model/serial numbers if provided.
    • Return, repair, or dispose of it as instructed.

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    Affected products

    • nGEN Generators

      Model: D138401

      Lot: All lots

    Why this matters

    Charring hazard

    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: D138401

    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.

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    Frequently Asked Questions

    Why was this product recalled?

    Charring hazard

    What should consumers do?

    Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it 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. Charring hazard

    When was this product recalled?

    This product was recalled on January 7, 2021.