RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Berlin Heart GmbhOfficial source

    Excor System Cannulas recall in Canada: blood loss and air embolism risk

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    In plain language

    This recall involves Excor System Cannulas sold in Canada. They are being recalled because they may breach, which could lead to massive blood loss or an air embolism. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer if you require additional information.

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    Affected products

    • Excor System - Apex Cannulas

      Model: C14A-040M, C18A-020, C22A-004, C27A-001

      Lot: All lots.

    • Excor System - Atrial Cannulas

      Model: C15V-040M, C19V-020M, C22V-002M, C22V-004, C23V-004, C25V-004

      Lot: All lots.

    • Excor System - Arterial Cannulas

      Model: C60G-002M, C60G-004M, C80G-021M, C80G-040M, C85G-002M, C85G-004

      Lot: All lots.

    • Excor System - Connecting Set For Cannulas

      Model: A06-009, A09-012

      Lot: All lots.

    Why this matters

    Massive blood loss and air embolism

    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: A06-009, A09-012, C14A-040M, C15V-040M, C18A-020, C19V-020M, C22A-004, C22V-002M, C22V-004, C23V-004, C25V-004, C27A-001, C60G-002M, C60G-004M, C80G-021M, C80G-040M, C85G-002M, C85G-004

    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?

    Massive blood loss and air embolism

    What should consumers do?

    Stop using the product immediately. 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. Massive blood loss and air embolism

    When was this product recalled?

    This product was recalled on August 17, 2023.

    Is the Berlin Heart Gmbh brand affected by this recall?

    Yes, Berlin Heart Gmbh products are affected by this recall. This recall involves Excor System Cannulas sold in Canada. They are being recalled because they may breach, which could lead to massive blood loss or an air embolism. Stop using the product and contact the manufacturer for more information.