Heartware Ventricular Assist System recall in Canada: performance issue
In plain language
This recall involves the Heartware Ventricular Assist System - HVAD Implant Kit sold in Canada. It's being recalled because the controller driveline cover may harden, making it difficult to access the driveline connector. This could delay access and potentially harm the patient from a prolonged pump stop. 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.
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Affected products
Heartware Ventricular Assist System - HVAD Implant Kit
Model: 1104
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Performance issue leading to potential patient harm
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: 1104
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?
Performance issue leading to potential patient harm
What should consumers do?
Stop using the product immediately. Contact the manufacturer for more 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?
Yes, there may be a health risk. Performance issue leading to potential patient harm
When was this product recalled?
This product was recalled on December 16, 2022.
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 - HVAD Implant Kit sold in Canada. It's being recalled because the controller driveline cover may harden, making it difficult to access the driveline connector. This could delay access and potentially harm the patient from a prolonged pump stop. Stop using the product and follow the return/repair steps in the official notice.