Device product

HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

Z-1106-2022

March 30, 2022

Class II

Product summary

Firm: Heartware, Inc.
Event: Event 90079
Status: Ongoing
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-1106-2022

Official wording

Reason: 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.

Code information: GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764

Distribution pattern: Finland and Turkey

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.