GORE Molding and Occlusion Balloon Catheter recall in Canada: Device malfunction
In plain language
This recall involves the GORE Molding and Occlusion Balloon Catheter sold in Canada. It's being recalled because the device may leak, causing it to not inflate or inflate improperly. 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 more information.
- Return the product as instructed.
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Affected products
GORE Molding and Occlusion Balloon Catheter
Model: MOB37
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Device malfunction
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: MOB37
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?
Device malfunction
What should consumers do?
Stop using the product immediately. Contact the manufacturer for more information. 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. Device malfunction
When was this product recalled?
This product was recalled on July 20, 2021.
Is the GORE brand affected by this recall?
Yes, GORE products are affected by this recall. This recall involves the GORE Molding and Occlusion Balloon Catheter sold in Canada. It's being recalled because the device may leak, causing it to not inflate or inflate improperly. Stop using the product and follow the return steps in the official notice.