RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026Arrow International LlcOfficial source

    Arrow-Trerotola Products recall in Canada: tip separation risk

    Share:

    In plain language

    This recall involves Arrow-Trerotola Percutaneous Thrombolytic Devices sold in Canada. They are being recalled because the device tip may separate during use. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Check the model and lot numbers provided in the recall notice.
    • Contact the manufacturer for additional information.

    Get alerts for recalls like this

    Get email alerts when new recalls affect products in this category.

    Categories (optional)

    No spam. Unsubscribe anytime. We only email when there's a relevant recall.

    Affected products

    • Arrow-Trerotola Percutaneous Thrombolytic Device Rotator Drive Unit

      Model: PT-65509-HFC

      Lot: 13F20D0386, 13F20M0183, 13F21G1344, 13F20G0176, 13F20A0359, 13F20B0140, 13F20J0139, 13F21H0213, 13F21B0224, 13F21C0366, 13F20F0576, 13F20J0547, 13F21E0078, 13F20C0593

    • Arrow-Trerotola Percutaneous Thrombolytic Device Kit

      Model: PT-45509, PT-65509

      Lot: 13F20J0545, 13F21G0226, 13F20D0127, 13F20A0209, 13F21C0365, 13F20C0427, 13F20D0402, 13F20G0285

    • Arrow-Trerotola Over-The-Wire Ptd Kit

      Model: PT-12709-WC, PT-65709-HFWC, PT-65709-W, PT-65709-WC

      Lot: 13F20G0284, 13F20B0053, 13F20C0094, 13F20G0361, 13F21C0748, 13F20G0566, 13F21C0080, 13F20F0577, 13F21A0354, 13F20H0756, 13F20F0578, 13F20F0230, 13F21A0353, 13F21E0415, 13F20L0282, 13F20A0323, 13F20M0182, 13F20L0514, 13F20C0596, 13F21C0747, 13F20B0139, 13F20K0849, 13F20L0283

    Why this matters

    Tip separation during use

    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: 13F20D0386, 13F20M0183, 13F21G1344, 13F20G0176, 13F20A0359, 13F20B0140, 13F20J0139, 13F21H0213, 13F21B0224, 13F21C0366, 13F20F0576, 13F20J0547, 13F21E0078, 13F20C0593, 13F20G0284, 13F20B0053, 13F20C0094, 13F20G0361, 13F21C0748, 13F20G0566, 13F21C0080, 13F20F0577, 13F21A0354, 13F20H0756, 13F20F0578, 13F20F0230, 13F21A0353, 13F21E0415, 13F20L0282, 13F20A0323, 13F20M0182, 13F20L0514, 13F20C0596, 13F21C0747, 13F20B0139, 13F20K0849, 13F20L0283, 13F20J0545, 13F21G0226, 13F20D0127, 13F20A0209, 13F21C0365, 13F20C0427, 13F20D0402, 13F20G0285

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: PT-12709-WC, PT-45509, PT-65509, PT-65509-HFC, PT-65709-HFWC, PT-65709-W, PT-65709-WC

    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.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Tip separation during use

    What should consumers do?

    Stop using the product immediately. Check the model and lot numbers provided in the recall notice. Contact the manufacturer for 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. Tip separation during use

    When was this product recalled?

    This product was recalled on January 18, 2022.

    Is the Arrow International Llc brand affected by this recall?

    Yes, Arrow International Llc products are affected by this recall. This recall involves Arrow-Trerotola Percutaneous Thrombolytic Devices sold in Canada. They are being recalled because the device tip may separate during use. Stop using the product and contact the manufacturer for more information.