HeartMate III LVAS Implant Kit recall in Canada: risk of serious injury or death
In plain language
This recall involves the HeartMate III LVAS Implant Kit sold in Canada. It's being recalled because outflow graft twists can cause serious adverse events such as hemodynamic compromise, thrombus, and death. Stop using the product and follow the return/repair steps in the official notice.
What to do
- Stop using the product immediately.
- Check model numbers.
- Contact your healthcare provider for further instructions.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
HeartMate III LVAS Implant Kit
Model: 106524US
Lot: Not applicable
Why this matters
Risk of serious injury or death
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: Not applicable
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 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?
Risk of serious injury or death
What should consumers do?
Stop using the product immediately. Check model numbers. Contact your healthcare provider for further instructions.
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. Risk of serious injury or death
When was this product recalled?
This product was recalled on May 1, 2018.