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Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Recalled May 25, 2022 · FDA recall Z-1105-2022 · Heartware
Hazard
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. · FDA Class II
Units
59 units
Sold at
Finland and Turkey
Description
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.
Product
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →