Medical devicesUpdated Jan 3, 2026Biosense Webster, Inc.Official source

    VARIPULSE Bi-Directional Ablation Catheter recall in Canada: labelling issue

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    In plain language

    This recall involves the VARIPULSE Bi-Directional Ablation Catheter sold in Canada. It's being recalled because of labelling and packaging issues. Stop using the product and follow the return/repair steps in the official notice.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer for more information.

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    Affected products

    • VARIPULSE Bi-Directional Ablation Catheter

      Model: D141201

      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: D141201

    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?

    This recall involves the VARIPULSE Bi-Directional Ablation Catheter sold in Canada. It's being recalled because of labelling and packaging issues. Stop using the product and follow the return/repair steps in the official notice.

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer for more 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 February 25, 2025.

    Is the Biosense Webster, Inc. brand affected by this recall?

    Yes, Biosense Webster, Inc. products are affected by this recall. This recall involves the VARIPULSE Bi-Directional Ablation Catheter sold in Canada. It's being recalled because of labelling and packaging issues. Stop using the product and follow the return/repair steps in the official notice.