Paclitaxel-Coated Balloons and Stents: No increased mortality risk in Canada
In plain language
This recall involves Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) used to treat Peripheral Arterial Disease (PAD) in Canada. Health Canada has determined there is no increased risk of mortality when these devices are used as intended. This update clarifies previous information regarding a potential risk.
What to do
- Consult with your healthcare professional if you have concerns.
- Follow your healthcare professional's advice regarding treatment options.
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Affected products
Specific affected products are listed in the official notice.
Do I have this product?
This recall applies to specific products. Details are listed in the official notice.
Frequently Asked Questions
Why was this product recalled?
This recall involves Paclitaxel-Coated Balloons (PCB) and Paclitaxel-Eluting Stents (PES) used to treat Peripheral Arterial Disease (PAD) in Canada. Health Canada has determined there is no increased risk of mortality when these devices are used as intended. This update clarifies previous information regarding a potential risk.
What should consumers do?
Consult with your healthcare professional if you have concerns. Follow your healthcare professional's advice regarding treatment options.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on February 20, 2024.