Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0475-2024 — HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

U.S. FDA — Device Enforcement · United States · 2023-10-31 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0475-2024
Date of alert
2023-10-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Heartware, Inc.
Product category
device
Product type
Devices
Reported risk: Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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.