FDA recall Z-1106-2022

Heartware, Inc. · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2022-03-30
Report date: 2022-05-25
Voluntary/Mandated: Voluntary: Firm initiated
Location: Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1106-2022