Medical devicesUpdated Jan 3, 2026COVIDIEN LLCOfficial source

    Chameleon™ PTA Balloon Catheter recall in Canada: performance issues

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    In plain language

    This recall involves the Chameleon™ PTA Balloon Catheter sold in Canada. It's being recalled because some devices failed balloon pressure testing, which could lead to performance issues. Contact the manufacturer for more information.

    What to do

    • Contact the manufacturer if you require additional information.

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    Affected products

    • Chameleon™ PTA Balloon Catheter

      Model: CH05-40-75US, CH06-40-75US, CH07-40-75US, CH08-40-75US, CH10-40-75US, CH12-40-75US

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Performance issues

    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: More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: CH05-40-75US, CH06-40-75US, CH07-40-75US, CH08-40-75US, CH10-40-75US, CH12-40-75US

    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?

    Performance issues

    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?

    Yes, there may be a health risk. Performance issues

    When was this product recalled?

    This product was recalled on September 26, 2024.

    Is the COVIDIEN LLC brand affected by this recall?

    Yes, COVIDIEN LLC products are affected by this recall. This recall involves the Chameleon™ PTA Balloon Catheter sold in Canada. It's being recalled because some devices failed balloon pressure testing, which could lead to performance issues. Contact the manufacturer for more information.