Ovation iX Abdominal Stent Graft System Platform recall in Canada: polymer leak
In plain language
This recall involves the Ovation iX Abdominal Stent Graft System Platform sold in Canada. It's being recalled because of a risk of polymer leaks during implantation. 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 if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
Ovation iX Abdominal Stent Graft System Platform
Model: TV-AB2080-J, TV-AB2380-J, TV-AB2680-J, TV-AB2980-J, TV-AB3480-J
Lot: All lots
Why this matters
Polymer leak during implantation
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: TV-AB2080-J, TV-AB2380-J, TV-AB2680-J, TV-AB2980-J, TV-AB3480-J
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?
Polymer leak during implantation
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Return, repair, or dispose of it 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?
Yes, there may be a health risk. Polymer leak during implantation
When was this product recalled?
This product was recalled on May 15, 2020.
Is the Ovation iX brand affected by this recall?
Yes, Ovation iX products are affected by this recall. This recall involves the Ovation iX Abdominal Stent Graft System Platform sold in Canada. It's being recalled because of a risk of polymer leaks during implantation. Stop using the product and follow the return/repair steps in the official notice.