Official recall record

Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES)

What the authority reported

UPDATED INFORMATION – February 20, 2024 Health Canada worked with manufacturers, clinicians, and other international health regulatory agencies to further assess the risk of increased mortality associated with the use of paclitaxel-coated devices used to treat peripheral arterial disease (PAD). Based on all available clinical evidence, Health Canada did not identify an increased risk of mortality associated with the use of these devices when used in accordance with the licensed indications. This information aligns with the U.S. Food and Drug Administration (US FDA) recommendations of July 11, 2023 and recommendations made by Health Canada's Scientific Advisory Committee on Medical Devices Used in the Cardiovascular System (SAC-MDUCS) in November 2023. This update applies to all paclitaxel-coated device models. Please note that the communication issued on May 6, 2019 (see below), is no longer reflective of the current Health Canada findings. Healthcare professionals are advised to use the paclitaxel-coated devices in accordance with the licensed indications outlined in the labeling material. May 6, 2019 A potential increased risk of long-term, all-cause mortality (at 2 years to 5 years) after the use of PCB and PES for the treatment of PAD was identified in a meta-analysis , which was published in the Journal of the American Heart Association (JAHA) in December 2018. 1 The reason for the potential increased risk of death is not yet known. Health Canada is currently evaluating this safety concern to determine if there is an increased long-term mortality risk associated with paclitaxel ‐ containing devices used for PAD treatment. Audience Healthcare professionals in hospitals, including hospital chiefs of medical staff, department of vascular surgery, interventional radiologists, and other relevant departments. Key Messages A study published in the Journal of the American Heart Association has identified a possible increased risk of death after the use of paclitaxel ‐ coated balloons (PCB) and paclitaxel-eluting stents (PES) to treat peripheral arterial disease (PAD). 1 The reason for this possible increased risk of death is not yet known. Health Canada is currently evaluating recently-published information on this risk. As a precautionary measure, healthcare professionals are advised to: Continue surveillance of patients who have been treated with paclitaxel-containing devices for treatment of PAD according to current standards of care. Weigh the risks and benefits for each patient when considering the use of PCB and PES in patients with PAD. Consider alternative treatment options rather than PCB and PES until additional analysis of the safety concern has been done. Consider limiting the use of PCB and PES to patients with critical limb ischemia (CLI). Inform patients of the possible additional risks associated with the use of paclitaxel-containing devices. Health Canada has also requested that manufacturers update the labelling of paclitaxel-containing devices to include details about this potential risk. Products affected * Device no longer licensed in Canada as of October 2018. **Other paclitaxel-containing devices are licensed for treatment of different diseases than PAD. These devices were not evaluated in the recently-published meta-analysis, but they could also potentially be associated with the increased risk of long-term mortality due to paclitaxel content. 1 Background PCB and PES are intended to treat de novo or restenotic lesions in the leg, including the superficial femoral and femoropopliteal arteries to mechanically open obstructed vessels. The release of paclitaxel from these devices is intended to reduce restenosis in the artery that can reduce blood flow. Paclitaxel-containing devices have also been licensed for the treatment of coronary artery disease, stenotic lesions in dysfunctional arteriovenous dialysis fistulae, and other diseases.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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