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Heartmate 3 lvas implant kit
Official notice
5 Apr 2024
Last checked
5 Apr 2024
An official Health Canada notice concerns Heartmate 3 lvas implant kit. There have been complaints of blood leaking out of the left ventricle or air entering the left ventricle or Left Ventricle Assist Device (LVAD) which are attributed to a leak path at the seal interface between the Heartmate 3 Left Ventricle Assist System (LVAS) inflow cannula and the titanium apical cuff. The blood leak or air entrainment has only been observed during the implantation procedure. Once the bleeding or air entrainment was resolved intraoperatively, the issue did not re-occur postoperatively. Abbott's investigation determined that in certain instances, routine manipulation of the pump or internal fluid pressures during implantation can result in a compressed sealing ring on one side, leading to a leak path on the opposite side. Recall Start Date: March 19, 2024 Published 2024-04-05.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75348
Official notice
2024-04-05
The hazard
The hazard
There have been complaints of blood leaking out of the left ventricle or air entering the left ventricle or Left Ventricle Assist Device (LVAD) which are attributed to a leak path at the seal interface between the Heartmate 3 Left Ventricle Assist System (LVAS) inflow cannula and the titanium apical cuff. The blood leak or air entrainment has only been observed during the implantation procedure. Once the bleeding or air entrainment was resolved intraoperatively, the issue did not re-occur postoperatively. Abbott's investigation determined that in certain instances, routine manipulation of the pump or internal fluid pressures during implantation can result in a compressed sealing ring on one side, leading to a leak path on the opposite side. Recall Start Date: March 19, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Thoratec, Heartmate 3 Lvas Implant Kit.
Source & status
Source & status
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Tier
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Recall details
Recall details
Recall number
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Documents, notices & source
See the official notice and source documents for full details.
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