HeartWare Ventricular Assist System recall in Canada: power loss risk
In plain language
This recall involves the HeartWare Ventricular Assist System, including the controller, AC adapter, DC adapter, alarm adapter, data cable, and battery, sold in Canada. It's being recalled because power and data cables can damage controller ports, potentially causing power loss or communication issues. 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.
- Contact Medtronic for updated instructions for use and patient manual.
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Affected products
HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER
Model: 1403US, 1407CA, 1420
Lot: More than 10 numbers, contact manufacturer.
HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER AC ADAPTER
Model: 1430CA
Lot: More than 10 numbers, contact manufacturer.
HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE CONTROLLER DC ADAPTER CONTROLLER
Model: 1440
Lot: More than 10 numbers, contact manufacturer.
HEARTWARE VENTRICULAR ASSIST SYSTEM - ALARM ADAPTER
Model: 1450
Lot: More than 10 numbers, contact manufacturer.
HEARTWARE VENTRICULAR ASSIST SYSTEM - DATA CABLE
Model: 1575
Lot: More than 10 numbers, contact manufacturer.
HEARTWARE VENTRICULAR ASSIST SYSTEM - HEARTWARE BATTERY
Model: 1650DE
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Risk of power loss or communication failure
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: 1403US, 1407CA, 1420, 1430CA, 1440, 1450, 1575, 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?
Risk of power loss or communication failure
What should consumers do?
Stop using the product immediately. Check model numbers if provided. Contact Medtronic for updated instructions for use and patient manual.
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 power loss or communication failure
When was this product recalled?
This product was recalled on March 25, 2021.
Is the HeartWare brand affected by this recall?
Yes, HeartWare products are affected by this recall. This recall involves the HeartWare Ventricular Assist System, including the controller, AC adapter, DC adapter, alarm adapter, data cable, and battery, sold in Canada. It's being recalled because power and data cables can damage controller ports, potentially causing power loss or communication issues. Stop using the product and follow the return/repair steps in the official notice.