HeartWare Controller recall in Canada: fluid ingress risk
In plain language
This recall involves the HeartWare Ventricular Assist System - HeartWare Controller sold in Canada. It's being recalled because some units may develop hairline cracks, allowing water or fluid to enter and cause malfunction. 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 for more information.
- Follow instructions for use and patient manual regarding water protection.
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Affected products
HeartWare Ventricular Assist System - HeartWare Controller
Model: 1407CA, 1420
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Malfunction due to fluid ingress
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: 1407CA, 1420
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?
Malfunction due to fluid ingress
What should consumers do?
Stop using the product immediately. Contact the manufacturer for more information. Follow instructions for use and patient manual regarding water protection.
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. Malfunction due to fluid ingress
When was this product recalled?
This product was recalled on September 28, 2018.
Is the HeartWare brand affected by this recall?
Yes, HeartWare products are affected by this recall. This recall involves the HeartWare Ventricular Assist System - HeartWare Controller sold in Canada. It's being recalled because some units may develop hairline cracks, allowing water or fluid to enter and cause malfunction. Stop using the product and follow the return/repair steps in the official notice.