Pipeline Flex Embolization Device recall in Canada: fracture risk
In plain language
This recall involves the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device With Shield Technology sold in Canada. It's being recalled because the device may fracture during use, which could lead to serious patient injury or death. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model/serial numbers if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
Pipeline Flex Embolization Device
Model: PED-325-30, PED-350-18, PED-375-10, PED-375-14, PED-400-18, PED-400-20
Lot: A946808, A946811, A946813, A946815, A946816, A946817, A947151, A947154, A947155
Pipeline Flex Embolization Device With Shield Technology
Model: PED2-325-10, PED2-325-12, PED2-325-14, PED2-325-16, PED2-350-16, PED2-375-18, PED2-375-20, PED2-400-16, PED2-400-20, PED2-400-25, PED2-425-16, PED2-450-16, PED2-450-18, PED2-450-20, PED2-450-25, PED2-475-12, PED2-475-35, PED2-500-14, PED2-500-18, PED2-500-20
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Internal injury risk from device fracture
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: A946808, A946811, A946813, A946815, A946816, A946817, A947151, A947154, A947155, More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: PED-325-30, PED-350-18, PED-375-10, PED-375-14, PED-400-18, PED-400-20, PED2-325-10, PED2-325-12, PED2-325-14, PED2-325-16, PED2-350-16, PED2-375-18, PED2-375-20, PED2-400-16, PED2-400-20, PED2-400-25, PED2-425-16, PED2-450-16, PED2-450-18, PED2-450-20, PED2-450-25, PED2-475-12, PED2-475-35, PED2-500-14, PED2-500-18, PED2-500-20
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?
Internal injury risk from device fracture
What should consumers do?
Stop using the product immediately. Check model/serial numbers if provided. Return, repair, or dispose of it 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. Internal injury risk from device fracture
When was this product recalled?
This product was recalled on March 3, 2020.
Is the Pipeline Flex Embolization Device brand affected by this recall?
Yes, Pipeline Flex Embolization Device products are affected by this recall. This recall involves the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device With Shield Technology sold in Canada. It's being recalled because the device may fracture during use, which could lead to serious patient injury or death. Stop using the product and follow the return/repair steps in the official notice.