HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- Company
- Heartware, Inc.
- Recall Initiated
- March 30, 2022
- Recall Number
- Z-1106-2022
- Firm Location
- Miami Lakes, FL
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
Lot / Code Info
GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764
Root Cause
Labeling design
Action Taken
Starting 30-Mar-2022, Medtronic initiated an Urgent Medical Device Notice to VAD Coordinators at customer sites by regional mail and visit in order to inform them of the errors and the corrections impacting the incorrect translation in Finland and Turkey for the HVAD" System. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients of the issues to the Patient Manual.