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

Is my product affected?

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

• UPC 00888707000420
• UPC 00888707007658

Check against the official notice below — it lists the full affected range.

What happened

HeartWare, Inc. is recalling 59 units of the HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0, distributed in Finland and Turkey. The recall addresses translation errors in Finnish and Turkish language versions found in the controller and monitor displays, as well as in the Instructions for Use, Patient Manual, and Emergency Responder Guide.

The affected devices carry either GTIN 00888707000420 or GTIN 00888707007658, with specific serial numbers identified in the recall. The source does not specify a remedy for consumers who may have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

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.

Details from the source

Reason for recall: 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. Distribution: Finland and Turkey Quantity: 59 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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All FDA (Device enforcement) recalls