Edwards Commander Delivery System recall in Canada: medical device issue
In plain language
This recall involves the Edwards Commander Delivery System used in medical procedures. It's being recalled because the balloon component may tear during use, which could lead to serious complications. 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 9610TF20, 9610TF23, 9610TF26, 9610TF29.
- Follow instructions from your healthcare provider or the official notice.
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Affected products
Edwards Commander Delivery System
Model: 9610TF20, 9610TF23, 9610TF26, 9610TF29
Lot: All lots
Why this matters
Medical device issue leading to complications
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: 9610TF20, 9610TF23, 9610TF26, 9610TF29
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 issue leading to complications
What should consumers do?
Stop using the product immediately. Check model numbers 9610TF20, 9610TF23, 9610TF26, 9610TF29. Follow instructions from your healthcare provider or the official notice.
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 issue leading to complications
When was this product recalled?
This product was recalled on April 29, 2019.
Is the Edwards brand affected by this recall?
Yes, Edwards products are affected by this recall. This recall involves the Edwards Commander Delivery System used in medical procedures. It's being recalled because the balloon component may tear during use, which could lead to serious complications. Stop using the product and follow the return/repair steps in the official notice.