HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Check against the official notice below — it lists the full affected range.
HeartWare, Inc. is recalling 510 units of the HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420, distributed in Finland and Turkey. The recall was initiated due to translation errors in Finnish and Turkish appearing on the controller and monitor displays, as well as in the Instructions for Use, Patient Manual, and Emergency Responder Guide.
The affected devices have GTIN 00888707000420 and bear specific serial numbers beginning with "CON" followed by numerical codes. The recall document does not specify a remedy or instructions for affected consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 510 units Lot/code info: GTIN 00888707000420, Serial Numbers: CON301559, CON301671, CON301680, CON301691, CON301692, CON301699, CON301714, CON301828, CON302225, CON302283, CON302286, CON302325, CON303175, CON303662, CON303733, CON303773, CON304089, CON304110, CON304225, CON304349, CON300543, CON300552, CON300553, CON300556, CON300619, CON300621, CON300623, CON300628, CON300638, CON300902, CON301367, CON301375, CON301485, CON301625, CON301674, CON301708, CON301870, CON301935, CON301943, CON301978, CON301996, CON302001, CON302013, CON302049, CON302113, CON302127, CON302138, CON302142, CON302143, CON302162, CON302165, CON302169, CON302172, CON302177, CON302180, CON302182, CON302183, CON302199, CON302227, CON302250, CON302262, CON302268, CON302281, CON302285, CON302299, CON302322, CON302327, CON302331, CON302336, CON302349, CON302366, CON302369, CON302371, CON302373, CON302374, CON302375, CON302387, CON302391, CON302394, CON302397, CON302399, CON302408, CON302412, CON302415, CON302420, CON302423, CON302436, CON302441, CON302443, CON302445, CON302446, CON302450, CON302451, CON302456, CON302458, CON302460, CON302465, CON302470, CON302471, CON302472, CON302474, CON302491, CON302496, CON302505, CON302508, CON302510, CON302511, CON302515, CON302522, CON302525, CON302535, CON302538, CON302539, CON302540, CON302543, CON302544, CON302546, CON302555, CON302556, CON302557, CON302560, CON302561, CON302562, CON302566, CON302567, CON302577, CON302581, CON302584, CON302595, CON302601, CON302613, CON302614, CON302619,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.