Edwards PASCAL Guide Sheath recall in Canada: Embolization risk
In plain language
This recall involves the Edwards PASCAL Transcatheter Mitral Valve Repair System - Guide Sheath sold in Canada. It's being recalled because an inspection issue may affect the inner lumen, which could lead to material embolization. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model and lot numbers.
- Return the product as instructed.
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Affected products
Transcatheter Mitral Valve Repair System - Guide Sheath
Model: 10000GS
Lot: 61130785
Why this matters
Embolization 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: 61130785
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 10000GS
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?
Embolization risk
What should consumers do?
Stop using the product immediately. Check model and lot 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?
Yes, there may be a health risk. Embolization risk
When was this product recalled?
This product was recalled on April 6, 2018.
Is the Edwards PASCAL brand affected by this recall?
Yes, Edwards PASCAL products are affected by this recall. This recall involves the Edwards PASCAL Transcatheter Mitral Valve Repair System - Guide Sheath sold in Canada. It's being recalled because an inspection issue may affect the inner lumen, which could lead to material embolization. Stop using the product and follow the return/repair steps in the official notice.