medical Class II Updated 2022-05-25

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

Recalled Product

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0

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 00888707000420, Serial Numbers: CON306040, CON306041, CON306042, CON306044, CON306045, CON306046, CON306047, CON306085, CON306086, CON306087, CON306088, CON306089, CON306090, CON306093, CON306098, CON306120, CON306123, CON306125, CON306127, CON306128, CON306129, CON306130, CON306131, CON306132, CON306268, CON306269, CON306292, CON306293, CON306336, CON306342, CON306435, CON306469, CON311478, CON318487, CON318711, CON318725; GTIN 00888707007658, Serial Numbers: CON413224, CON413247, CON413272, CON413279, CON413281, CON413282, CON413288, CON413289, CON413387, CON413417, CON413419, CON413420, CON413447, CON413448, CON413460, CON413910, CON413939, CON413948, CON415371, CON415373, CON416868, CON416871, CON416872
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