medical Class II Updated 2022-05-25

Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System, Model Num

Recalled Product

HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

Hazard / Issue

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.

Issued by

FDA

Distribution: Finland and Turkey
Lot/Code Info: GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764
View official government recall

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