Heartmate 3 LVAS Implant Kit recall in Canada: performance issues
In plain language
This recall involves the Heartmate 3 LVAS Implant Kit sold in Canada. It's being recalled because of performance issues that could lead to blood leaks or air entering the device during implantation. Contact the manufacturer for more information.
What to do
- Contact the manufacturer for additional information.
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Affected products
Heartmate 3 LVAS Implant Kit
Model: 106524, 106524US
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Performance issues leading to blood leaks or air entrainment
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: 106524, 106524US
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?
Performance issues leading to blood leaks or air entrainment
What should consumers do?
Contact the manufacturer for additional 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. Performance issues leading to blood leaks or air entrainment
When was this product recalled?
This product was recalled on April 5, 2024.
Is the THORATEC CORPORATION brand affected by this recall?
Yes, THORATEC CORPORATION products are affected by this recall. This recall involves the Heartmate 3 LVAS Implant Kit sold in Canada. It's being recalled because of performance issues that could lead to blood leaks or air entering the device during implantation. Contact the manufacturer for more information.