GORE EXCLUDER System recall in Canada: catheter component separation
In plain language
This recall involves the GORE EXCLUDER System, including AAA Endoprosthesis and Iliac Branch Endoprosthesis, sold in Canada. It's being recalled because a component of the catheter may separate. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Contact the manufacturer for lot and model number information.
- Follow the instructions provided by the manufacturer or healthcare professional.
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Affected products
GORE EXCLUDER AAA Endoprosthesis
Model: More than 10 numbers, contact manufacturer.
Lot: More than 10 numbers, contact manufacturer.
GORE EXCLUDER Iliac Branch Endoprosthesis - Iliac Branch Component
Model: CEB231010, CEB231210, CEB231410
Lot: More than 10 numbers, contact manufacturer.
GORE EXCLUDER Iliac Branch Endoprosthesis - Internal Iliac Component
Model: HGB161007, HGB161207, HGB161407
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Catheter component separation
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: CEB231010, CEB231210, CEB231410, HGB161007, HGB161207, HGB161407, More than 10 numbers, contact manufacturer.
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?
Catheter component separation
What should consumers do?
Stop using the product immediately. Contact the manufacturer for lot and model number information. Follow the instructions provided by the manufacturer or healthcare professional.
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. Catheter component separation
When was this product recalled?
This product was recalled on January 24, 2020.
Is the GORE EXCLUDER brand affected by this recall?
Yes, GORE EXCLUDER products are affected by this recall. This recall involves the GORE EXCLUDER System, including AAA Endoprosthesis and Iliac Branch Endoprosthesis, sold in Canada. It's being recalled because a component of the catheter may separate. Stop using the product and follow the return steps in the official notice.