Edwards PASCAL Transcatheter Valve Repair System (2019-04-28)
In plain language
This recall involves the Edwards PASCAL Transcatheter Valve Repair System used in Canada. It's being recalled because a procedural factor may lead to air bubbles, which could cause an air embolism. Healthcare professionals should review updated training materials and de-airing techniques.
What to do
- Healthcare professionals should review the updated physician training materials.
- Ensure proper de-airing tools and techniques are used.
- Report any adverse events to Health Canada.
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Affected products
Edwards PASCAL Transcatheter Valve Repair System
Model: 10000GSCL, 10000GSCLUS, 10000GSCUST, 10000ISCL, 10000ISCLUS, 10000ISCUST, 10000ISM, 10000ISMCL
Lot: All lots
Why this matters
Air embolism 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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 10000GSCL, 10000GSCLUS, 10000GSCUST, 10000ISCL, 10000ISCLUS, 10000ISCUST, 10000ISM, 10000ISMCL
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?
Air embolism risk
What should consumers do?
Healthcare professionals should review the updated physician training materials. Ensure proper de-airing tools and techniques are used. Report any adverse events to Health Canada.
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. Air embolism risk
When was this product recalled?
This product was recalled on May 24, 2019.
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 Valve Repair System used in Canada. It's being recalled because a procedural factor may lead to air bubbles, which could cause an air embolism. Healthcare professionals should review updated training materials and de-airing techniques.