THERMOCOOL SMARTTOUCH SF Catheter recall in Canada: Char formation risk
In plain language
This recall involves THERMOCOOL SMARTTOUCH SF Uni-Directional and Bi-Directional Navigation Catheters sold in Canada. They are being recalled because of a higher than expected rate of char formation. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and lot numbers.
- Contact Biosense Webster Inc. for further instructions.
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Affected products
THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter
Model: D134701, D134702, D134703
Lot: D134701, D134702, D134703
THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter
Model: D134801, D134802, D134803, D134804, D134805
Lot: D134801, D134802, D134803, D134804, D134805
Why this matters
Char formation 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: D134701, D134702, D134703, D134801, D134802, D134803, D134804, D134805
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: D134701, D134702, D134703, D134801, D134802, D134803, D134804, D134805
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?
Char formation risk
What should consumers do?
Stop using the product immediately. Check model and lot numbers. Contact Biosense Webster Inc. for further instructions.
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. Char formation risk
When was this product recalled?
This product was recalled on November 28, 2018.
Is the THERMOCOOL SMARTTOUCH SF brand affected by this recall?
Yes, THERMOCOOL SMARTTOUCH SF products are affected by this recall. This recall involves THERMOCOOL SMARTTOUCH SF Uni-Directional and Bi-Directional Navigation Catheters sold in Canada. They are being recalled because of a higher than expected rate of char formation. Stop using the product and follow the return/repair steps in the official notice.