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Heartmate ii™ and heartmate 3™ left ventricular assist systems
Official notice
6 Mar 2024
Last checked
6 Mar 2024
An official Health Canada notice concerns Heartmate ii™ and heartmate 3™ left ventricular assist systems. Abbott is notifying customers of a planned update to instructions for use associated with observed outflow graft deformation known as "extrinsic outflow graft obstruction" (EOGO) associated with the Heartmate 3™ left ventricular assist system (LVAS) and Heartmate II™ LVAS. Significant EOGO will manifest clinically as as a persistent low flow alarm under certain circumstances in some patients, and in such cases, may impair the ability of the Heartmate LVAS to provide adequate hemodynamic support. Recall start date: February 20, 2024 Published 2024-03-06.
What to do now
Contact the manufacturer if you require additional information .
Recall number
75183
Official notice
2024-03-06
The hazard
The hazard
Abbott is notifying customers of a planned update to instructions for use associated with observed outflow graft deformation known as "extrinsic outflow graft obstruction" (EOGO) associated with the Heartmate 3™ left ventricular assist system (LVAS) and Heartmate II™ LVAS. Significant EOGO will manifest clinically as as a persistent low flow alarm under certain circumstances in some patients, and in such cases, may impair the ability of the Heartmate LVAS to provide adequate hemodynamic support. Recall start date: February 20, 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.
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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.
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Company & contacts
Company & contacts
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Brand: Thoratec, Heartmate Ii™ And Heartmate 3™ Left Ventricular Assist.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
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