Edwards SAPIEN 3 Ultra recall in Canada: difficulty withdrawing device
In plain language
This recall involves the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System sold in Canada. It's being recalled because burst balloons can make it difficult to withdraw the device from a patient. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers.
- Return the product as instructed.
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Affected products
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System
Model: 9630TF20, 9630TF23, 9630TF26, 9630TF29
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: 9630TF20, 9630TF23, 9630TF26, 9630TF29
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 Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System sold in Canada. It's being recalled because burst balloons can make it difficult to withdraw the device from a patient. Stop using the product and follow the return/repair steps in the official notice.
What should consumers do?
Stop using the product immediately. Check model numbers. Return the product as instructed.
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 July 16, 2019.
Is the Edwards brand affected by this recall?
Yes, Edwards products are affected by this recall. This recall involves the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System sold in Canada. It's being recalled because burst balloons can make it difficult to withdraw the device from a patient. Stop using the product and follow the return/repair steps in the official notice.