Official recall record

Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems

Health Canada — Medical Devices · 2024-03-06 · CanadaType I

Issuing authority: Health Canada — Medical Devices
Published: 2024-03-06
Country of alert: Canada
Alert level: Type I
Alert type: recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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