Dual Collapser recall in Canada: Medical device malfunction risk
In plain language
This recall involves the Dual Collapser medical device sold in Canada. It's being recalled because a misalignment may prevent the device from collapsing properly. This could affect the function of a heart valve during surgery. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check the model and lot numbers provided.
- Return or dispose of it as instructed.
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Affected products
Dual Collapser
Model: ICV1349, ICV1350
Lot: 2001300339, 2002130159, 2002200196, 2001300341, 2002060224, 2002130160, 2002130161, 2002130162, 2002200198, 2002200199
Why this matters
Medical device malfunction 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: 2001300339, 2002130159, 2002200196, 2001300341, 2002060224, 2002130160, 2002130161, 2002130162, 2002200198, 2002200199
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: ICV1349, ICV1350
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?
Medical device malfunction risk
What should consumers do?
Stop using the product immediately. Check the model and lot numbers provided. Return 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. Medical device malfunction risk
When was this product recalled?
This product was recalled on September 18, 2020.