VARIPULSE Bi-Directional Ablation Catheter recall in Canada: labelling issue
In plain language
This recall involves the VARIPULSE Bi-Directional Ablation Catheter sold in Canada. It's being recalled because of labelling and packaging issues. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact the manufacturer for more information.
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Affected products
VARIPULSE Bi-Directional Ablation Catheter
Model: D141201
Lot: All lots
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: D141201
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?
This recall involves the VARIPULSE Bi-Directional Ablation Catheter sold in Canada. It's being recalled because of labelling and packaging issues. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Contact the manufacturer for more 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?
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 25, 2025.
Is the Biosense Webster, Inc. brand affected by this recall?
Yes, Biosense Webster, Inc. products are affected by this recall. This recall involves the VARIPULSE Bi-Directional Ablation Catheter sold in Canada. It's being recalled because of labelling and packaging issues. Stop using the product and follow the return/repair steps in the official notice.