Heartware Ventricular Assist System recall in Canada: performance issues
In plain language
This recall involves Heartware Ventricular Assist System – Heartware Batteries sold in Canada. It's being recalled because of performance issues that could lead to the device failing to deliver power. 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 additional information.
- Respond to all battery-related alarms.
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Affected products
Heartware Ventricular Assist System – Heartware Battery
Model: 1650DE
Lot: All lots
Why this matters
Device failure due to power loss
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: All lots
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 1650DE
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?
Device failure due to power loss
What should consumers do?
Stop using the product immediately. Contact the manufacturer for additional information. Respond to all battery-related alarms.
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. Device failure due to power loss
When was this product recalled?
This product was recalled on July 4, 2022.
Is the Heartware Inc. brand affected by this recall?
Yes, Heartware Inc. products are affected by this recall. This recall involves Heartware Ventricular Assist System – Heartware Batteries sold in Canada. It's being recalled because of performance issues that could lead to the device failing to deliver power. Stop using the product and follow the return/repair steps in the official notice.