Product Wiki · Recalls · Health Canada — Medical Devices

Heartware Ventricular Assist System - HVAD Implant Kit (2020-04-06) — recall 61251

Health Canada — Medical Devices · Canada · 2020-05-15 · Type II

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
61251
Date of alert
2020-05-15
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The outflow graft may be subject to tears and the strain relief screw may break during the pre-implant pump assembly and attachment to the HVAD pump. Manufacturer is providing additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure. No action is needed for patients currently implanted with an HVAD pump since the potential for damage applies to the pre-implant outflow graft and strain relief assembly procedure.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heartware-ventricular-assist-s

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.