Product Wiki · Recalls · Health Canada — Medical Devices

Heartmate II™ and Heartmate 3™ Left Ventricular Assist Systems — recall 75183

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

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
75183
Date of alert
2024-03-06
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heartmate-iitm-and-heartmate-3

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.