IntraClude Intra-aortic Occlusion Device recall in Canada: balloon rupture risk
In plain language
This recall involves the IntraClude Intra-aortic Occlusion Device (Model ICF100) sold in Canada. It's being recalled because the balloon may rupture during use. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the model and lot numbers.
- Contact Edwards Lifesciences for return instructions.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
IntraClude Intra-aortic Occlusion Device
Model: ICF100
Lot: 60972890, 61078031, 61097633, 61139239, 61259627, 61259628, 61713218, 61723505, 61898939
Why this matters
Balloon rupture 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: 60972890, 61078031, 61097633, 61139239, 61259627, 61259628, 61713218, 61723505, 61898939
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: ICF100
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?
Balloon rupture risk
What should consumers do?
Stop using the product immediately. Check the model and lot numbers. Contact Edwards Lifesciences for return 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. Balloon rupture risk
When was this product recalled?
This product was recalled on July 16, 2019.
Is the IntraClude brand affected by this recall?
Yes, IntraClude products are affected by this recall. This recall involves the IntraClude Intra-aortic Occlusion Device (Model ICF100) sold in Canada. It's being recalled because the balloon may rupture during use. Stop using the product and follow the return steps in the official notice.