CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath (2021-02-25)
In plain language
This recall involves the CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath sold in Canada. It's being recalled because a valve can dislodge, which could lead to bleeding or, in rare cases, an air embolism. 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
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
Model: D138501, D138502, D138503
Lot: All lots
Why this matters
Air embolism risk
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: D138501, D138502, D138503
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?
Air embolism risk
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. Air embolism risk
When was this product recalled?
This product was recalled on March 18, 2021.
Is the CARTO VIZIGO brand affected by this recall?
Yes, CARTO VIZIGO products are affected by this recall. This recall involves the CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath sold in Canada. It's being recalled because a valve can dislodge, which could lead to bleeding or, in rare cases, an air embolism. Stop using the product and follow the return/repair steps in the official notice.