HeartWare Ventricular Assist System recall in Canada: pump stoppage risk
In plain language
This recall involves the HeartWare Ventricular Assist System Battery Charger and AC Adapter sold in Canada. It's being recalled because incorrect use of the AC adapter can damage the controller, potentially leading to pump stoppage. 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 if provided.
- Return, repair, or dispose of it as instructed.
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Affected products
HeartWare Ventricular Assist System - HeartWare Battery Charger
Model: 1610CA
Lot: More than 10 numbers, contact manufacturer.
HeartWare Ventricular Assist System - Battery Charger AC Adapter
Model: 1640CA
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Risk of pump stoppage leading to patient harm 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: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: 1610CA, 1640CA
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 pump stoppage leading to patient harm or death
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Return, repair, or dispose of it as instructed.
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 pump stoppage leading to patient harm or death
When was this product recalled?
This product was recalled on February 28, 2020.
Is the HeartWare brand affected by this recall?
Yes, HeartWare products are affected by this recall. This recall involves the HeartWare Ventricular Assist System Battery Charger and AC Adapter sold in Canada. It's being recalled because incorrect use of the AC adapter can damage the controller, potentially leading to pump stoppage. Stop using the product and follow the return/repair steps in the official notice.