Pulmonary Vein Ablation Catheter Gold (2019-03-03)
In plain language
This recall involves the Pulmonary Vein Ablation Catheter Gold sold in Canada. It's being recalled because it has a higher risk of phrenic nerve injury than predicted. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact your healthcare provider for guidance.
- Follow the instructions from the manufacturer or Health Canada.
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Affected products
Pulmonary Vein Ablation Catheter Gold
Model: 990078
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Phrenic nerve injury risk
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 990078
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.
Frequently Asked Questions
Why was this product recalled?
Phrenic nerve injury risk
What should consumers do?
Stop using the product immediately. Contact your healthcare provider for guidance. Follow the instructions from the manufacturer or Health Canada.
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. Phrenic nerve injury risk
When was this product recalled?
This product was recalled on March 22, 2019.