Fred® Flow Re-Direction Endoluminal Device recall in Canada: performance issue
In plain language
This recall involves the Fred® Flow Re-Direction Endoluminal Device sold in Canada. It's being recalled because it may not perform as intended due to an incorrect inner stent length. Stop using the product and follow the return steps in the official notice.
What to do
- Stop using the product immediately.
- Check the lot or serial numbers provided.
- Return the product for replacement as instructed.
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Affected products
Fred® Flow Re-Direction Endoluminal Device
Model: FRED3536, FRED4012, FRED4539, FRED5514, FRED5526
Lot: 20092955K, 20092859F, 200922536, 20071655K, 20081255H, 2009085AU, 20092853Z, 20092957L
Date codes: manufactured between June 1, 2020, and September 29, 2020
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 date code
Date codes are usually printed near the best-before date or on the packaging seam.
Affected date codes: manufactured between June 1, 2020, and September 29, 2020
- 3
Check the lot number
Lot numbers identify specific production batches.
Affected lots: 20092955K, 20092859F, 200922536, 20071655K, 20081255H, 2009085AU, 20092853Z, 20092957L
- 4
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: FRED3536, FRED4012, FRED4539, FRED5514, FRED5526
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 Fred® Flow Re-Direction Endoluminal Device sold in Canada. It's being recalled because it may not perform as intended due to an incorrect inner stent length. Stop using the product and follow the return steps in the official notice.
What should consumers do?
Stop using the product immediately. Check the lot or serial numbers provided. Return the product for replacement 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?
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 November 4, 2024.
Is the Microvention, Inc. brand affected by this recall?
Yes, Microvention, Inc. products are affected by this recall. This recall involves the Fred® Flow Re-Direction Endoluminal Device sold in Canada. It's being recalled because it may not perform as intended due to an incorrect inner stent length. Stop using the product and follow the return steps in the official notice.