10Fore™ Hemostasis Valve recall in Canada: performance issue
In plain language
This recall involves the 10Fore™ Hemostasis Valve sold in Canada. It's being recalled because of a manufacturing quality concern that could affect its performance. Contact the manufacturer if you require additional information.
What to do
- Contact the manufacturer if you require additional information.
- Check the model and lot numbers to see if your product is affected.
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Affected products
10Fore™ Hemostasis Valve
Model: MAPTEN4, MAPTEN42, MAPTEN452
Lot: H3076189, H3098829, H3098831, H3111155, H3111156, H3111162, H3152503, H3152504, H3155611, H3155614, H3173674, H3186901
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: H3076189, H3098829, H3098831, H3111155, H3111156, H3111162, H3152503, H3152504, H3155611, H3155614, H3173674, H3186901
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: MAPTEN4, MAPTEN42, MAPTEN452
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?
This recall involves the 10Fore™ Hemostasis Valve sold in Canada. It's being recalled because of a manufacturing quality concern that could affect its performance. Contact the manufacturer if you require additional information.
What should consumers do?
Contact the manufacturer if you require additional information. Check the model and lot numbers to see if your product is affected.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on July 30, 2025.
Is the Merit Medical Systems Inc. brand affected by this recall?
Yes, Merit Medical Systems Inc. products are affected by this recall. This recall involves the 10Fore™ Hemostasis Valve sold in Canada. It's being recalled because of a manufacturing quality concern that could affect its performance. Contact the manufacturer if you require additional information.