Medical device recall in Canada: Ablation catheters may cause internal injury
In plain language
This recall involves percutaneous radiofrequency ablation catheters from several manufacturers sold in Canada. They are being recalled because they may cause a rare but serious internal injury called atrioesophageal fistula (AEF). This can lead to severe health complications or death. Healthcare professionals are advised to watch for early signs/symptoms of AEF in patients with a recent history of AF ablation.
What to do
- Healthcare professionals should be aware of the risk of atrioesophageal fistula (AEF).
- Watch for early signs/symptoms of AEF in patients with a recent history of AF ablation.
- Prompt diagnosis and timely management may improve patient outcomes.
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Affected products
Specific affected products are listed in the official notice.
Why this matters
Internal injury (atrioesophageal fistula)
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?
Internal injury (atrioesophageal fistula)
What should consumers do?
Healthcare professionals should be aware of the risk of atrioesophageal fistula (AEF). Watch for early signs/symptoms of AEF in patients with a recent history of AF ablation. Prompt diagnosis and timely management may improve patient outcomes.
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. Internal injury (atrioesophageal fistula)
When was this product recalled?
This product was recalled on April 16, 2018.