Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- Recall date
- March 30, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1106-2022
- FDA classification
- Class II
- Brand / firm
- Heartware, Inc.
- Sold / distributed
- Finland and Turkey
Why it was recalled
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
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