Medical device recall in Canada: Strata II, Delta, and CSF-Flow Control Valves
In plain language
This recall involves Strata II, Delta, and CSF-Flow Control Valves and Shunts sold in Canada. They are being recalled because the radiopaque markings may not be clearly visible under X-ray imaging. This could make it difficult to determine pressure settings and flow direction after implantation. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact Medtronic Inc. for more information.
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Affected products
Specific affected products are listed in the official notice.
Why this matters
Difficulty determining pressure settings and flow direction
Do I have this product?
This recall applies to specific products. Details are listed in the official notice.
Frequently Asked Questions
Why was this product recalled?
Difficulty determining pressure settings and flow direction
What should consumers do?
Stop using the product immediately. Contact Medtronic Inc. for more information.
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. Difficulty determining pressure settings and flow direction
When was this product recalled?
This product was recalled on February 5, 2021.