HeartMate 3 System Controller recall in Canada: water ingress risk
In plain language
This recall involves the HeartMate 3 LVAS Implant Kit and HeartMate 3 System Controller sold in Canada. It's being recalled because a lifted user interface membrane could allow water to enter the controller, potentially affecting its performance. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Contact the manufacturer, Abbott Medical, for more information.
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Affected products
HeartMate 3 LVAS Implant Kit
Model: 106524US
Lot: More than 10 numbers, contact manufacturer.
HeartMate 3 System Controller
Model: 106531US
Lot: More than 10 numbers, contact manufacturer.
HeartMate 3 System Controller Low Flow 2.0
Model: 106531LF2
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Water ingress 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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 106524US, 106531LF2, 106531US
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?
Water ingress risk
What should consumers do?
Stop using the product immediately. Contact the manufacturer, Abbott Medical, 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. Water ingress risk
When was this product recalled?
This product was recalled on July 30, 2024.
Is the ABBOTT MEDICAL brand affected by this recall?
Yes, ABBOTT MEDICAL products are affected by this recall. This recall involves the HeartMate 3 LVAS Implant Kit and HeartMate 3 System Controller sold in Canada. It's being recalled because a lifted user interface membrane could allow water to enter the controller, potentially affecting its performance. Stop using the product and follow the return/repair steps in the official notice.