VNS Therapy SenTiva® Duo Generator recall in Canada: Performance issues
In plain language
This recall involves the VNS Therapy SenTiva® Duo Generator sold in Canada. It's being recalled because of performance issues that may cause a loss of therapy or inability to make therapy changes. Healthcare providers will be notified and given instructions on how to respond.
What to do
- Customers will be notified by the manufacturer.
- Follow the instructions provided by the manufacturer.
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Affected products
VNS Therapy SenTiva® Duo Generator
Model: 1000-D
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Loss of therapy or inability to make therapy changes
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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 1000-D
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?
Loss of therapy or inability to make therapy changes
What should consumers do?
Customers will be notified by the manufacturer. Follow the instructions provided by the manufacturer.
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. Loss of therapy or inability to make therapy changes
When was this product recalled?
This product was recalled on February 5, 2025.
Is the Livanova Usa, Inc. brand affected by this recall?
Yes, Livanova Usa, Inc. products are affected by this recall. This recall involves the VNS Therapy SenTiva® Duo Generator sold in Canada. It's being recalled because of performance issues that may cause a loss of therapy or inability to make therapy changes. Healthcare providers will be notified and given instructions on how to respond.