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Heartware, Inc. Recall 90079

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

Heartware, Inc. Recall 90079 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1105-2022
Event ID90079
Event DescriptionHeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Product TypeDevices
DistributionFinland and Turkey
Quantity59 units
Recall ReasonFinnish 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.
Device Classification20220525
Device Code InfoGTIN 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
Center Classification Date20220517
Recall Initiation Date20220330
Recalling FirmHeartware, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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