HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Check against the official notice below — it lists the full affected range.
HeartWare, Inc. is recalling 667 units of the HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit distributed in Finland and Turkey due to translation errors in Finnish and Turkish. The errors appear in the controller and monitor displays as well as in the Instructions for Use, Patient Manual, and Emergency Responder Guide. The affected devices are identified by GTIN 00888707001700 and carry specific serial numbers listed in the recall documentation.
The recall notice 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: 667 units Lot/code info: GTIN 00888707001700, Serial Numbers: CON300826, CON302649, CON304346, CON305438, CON305669, CON309302, CON309306, CON309974, CON312894, CON313111, CON313129, CON313154, CON314788, CON314789, CON314903, CON314929, CON315066, CON315120, CON315384, CON300826, CON304248, CON304346, CON304363, CON304943, CON300612, CON300622, CON302530, CON302655, CON302814, CON303005, CON303057, CON303093, CON303132, CON303368, CON303549, CON303571, CON303936, CON304027, CON304028, CON304282, CON304302, CON304318, CON304322, CON304327, CON304328, CON304358, CON304360, CON304362, CON304381, CON304451, CON304453, CON304587, CON304596, CON304600, CON304610, CON304614, CON304620, CON304628, CON304645, CON304649, CON304793, CON304797, CON304889, CON304965, CON305110, CON305123, CON305124, CON305142, CON305146, CON305148, CON305150, CON305277, CON305282, CON305325, CON315244, CON314763, CON315247, CON314577, CON313809, CON314057, CON315260, CON315259, CON315246, CON314770, CON314120, CON314193, CON314339, CON314021, CON314211, CON314068, CON313626, CON310360, CON314188, CON314084, CON314016, CON314085, CON314027, CON314346, CON314087, CON313967, CON314024, CON314187, CON313993, CON311103, CON314148, CON313513, CON313068, CON313452, CON312745, CON313489, CON312959, CON312899, CON313164, CON312896, CON313107, CON313161, CON313166, CON312898, CON313162, CON313232, CON312948, CON312897, CON313109, CON313183, CON313187, CON313168, CON312900, CON313095, CON313165, CON310155, CON309602, CON309853, CON309850,
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.