Heartware Ventricular Assist System - HVAD Implant Kit (2020-04-06)
In plain language
This recall involves the Heartware Ventricular Assist System - HVAD Implant Kit sold in Canada. It's being recalled because the outflow graft may tear and the strain relief screw may break during assembly. No action is needed for patients currently implanted with an HVAD pump.
What to do
- No action is needed for patients currently implanted with an HVAD pump.
- Healthcare professionals should follow additional assembly steps provided by the manufacturer.
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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
Tears and breakage during assembly
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?
Tears and breakage during assembly
What should consumers do?
No action is needed for patients currently implanted with an HVAD pump. Healthcare professionals should follow additional assembly steps provided by the manufacturer.
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. Tears and breakage during assembly
When was this product recalled?
This product was recalled on May 15, 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 - HVAD Implant Kit sold in Canada. It's being recalled because the outflow graft may tear and the strain relief screw may break during assembly. No action is needed for patients currently implanted with an HVAD pump.