Heartware Ventricular Assist System recall in Canada: performance issue
In plain language
This recall involves the Heartware Ventricular Assist System - Heartware Monitor sold in Canada. It's being recalled because a programming error could prevent the pump from restarting, potentially harming patients. This recall is for healthcare professionals. Contact the manufacturer for more information.
What to do
- Contact the manufacturer if you require additional information.
Get alerts for recalls like this
Get email alerts when new recalls affect products in this category.
Affected products
Heartware Ventricular Assist System - Heartware Monitor
Model: 1521CA, 1522CA
Lot: More than 10 numbers, contact manufacturer.
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: 1521CA, 1522CA
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?
This recall involves the Heartware Ventricular Assist System - Heartware Monitor sold in Canada. It's being recalled because a programming error could prevent the pump from restarting, potentially harming patients. This recall is for healthcare professionals. Contact the manufacturer for more information.
What should consumers do?
Contact the manufacturer if you require additional information.
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?
A potential safety risk has been identified with this product. Stop using it immediately and follow the instructions in the official recall notice.
When was this product recalled?
This product was recalled on January 16, 2025.
Is the Heartware Inc. brand affected by this recall?
Yes, Heartware Inc. products are affected by this recall. This recall involves the Heartware Ventricular Assist System - Heartware Monitor sold in Canada. It's being recalled because a programming error could prevent the pump from restarting, potentially harming patients. This recall is for healthcare professionals. Contact the manufacturer for more information.