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

Recall Z-0582-2019 — Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplanta

U.S. FDA — Device Enforcement · United States · 2018-11-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0582-2019
Date of alert: 2018-11-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Heartware, Inc.
Product category: device
Product type: Devices

Reported risk: HVAD Battery Charger units manufactured with wrong inductors.

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.

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.

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