RecallGuide.ca
    Medical devices••Updated Jan 3, 2026•Pipeline Flex•Official source

    Pipeline Flex Embolization Device recall in Canada: serious injury risk

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    In plain language

    This recall involves the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology sold in Canada. It's being recalled because a part of the device may fracture during use, which could lead to serious injury or death. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.

    What to do

    • Stop using the affected products immediately.
    • Check the model and lot numbers of your devices.
    • Return the affected products as instructed by Medtronic.

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    Affected products

    • Pipeline Flex Embolization Device

      Model: PED-325-25, PED-475-20, PED-500-14

      Lot: A815692, A815694, A885864, A887937

    • Pipeline Flex Embolization Device with Shield Technology

      Model: PED2-250-10, PED2-250-14, PED2-250-16, PED2-275-14, PED2-275-16, PED2-300-10, PED2-300-12, PED2-350-20, PED2-400-16, PED2-400-18, PED2-425-10

      Lot: More than 10 numbers, contact manufacturer.

    Why this matters

    Serious injury or death due to device fracture

    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: A815692, A815694, A885864, A887937, More than 10 numbers, contact manufacturer.

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: PED-325-25, PED-475-20, PED-500-14, PED2-250-10, PED2-250-14, PED2-250-16, PED2-275-14, PED2-275-16, PED2-300-10, PED2-300-12, PED2-350-20, PED2-400-16, PED2-400-18, PED2-425-10

    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?

    Serious injury or death due to device fracture

    What should consumers do?

    Stop using the affected products immediately. Check the model and lot numbers of your devices. Return the affected products as instructed by Medtronic.

    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. Serious injury or death due to device fracture

    When was this product recalled?

    This product was recalled on July 27, 2021.

    Is the Pipeline Flex brand affected by this recall?

    Yes, Pipeline Flex products are affected by this recall. This recall involves the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology sold in Canada. It's being recalled because a part of the device may fracture during use, which could lead to serious injury or death. Healthcare professionals should stop using the affected products and follow the return steps in the official notice.