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U.S. Department of Health and Human Services

Class 2 Device Recall HeartWare Ventricular Assist Device (HVAD) System

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  Class 2 Device Recall HeartWare Ventricular Assist Device (HVAD) System see related information
Date Initiated by Firm March 30, 2022
Create Date May 17, 2022
Recall Status1 Open3, Classified
Recall Number Z-1106-2022
Recall Event ID 90079
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Code Information GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764 
Recalling Firm/
Manufacturer		 Heartware, Inc.
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact MCS Customer Service
877-367-4823
Manufacturer 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.
FDA Determined
Cause 2		 Labeling design
Action 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.
Distribution Finland and Turkey
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Medtronic
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