| Class 2 Device Recall HeartWare Ventricular Assist Device (HVAD) System | |
Date Initiated by Firm | March 30, 2022 |
Create Date | May 17, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1105-2022 |
Recall Event ID |
90079 |
PMA Number | P100047 |
Product Classification |
Ventricular (assist) bypass - Product Code DSQ
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Product | HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0 |
Code Information |
GTIN 00888707000420, Serial Numbers: CON306040, CON306041, CON306042, CON306044, CON306045, CON306046, CON306047, CON306085, CON306086, CON306087, CON306088, CON306089, CON306090, CON306093, CON306098, CON306120, CON306123, CON306125, CON306127, CON306128, CON306129, CON306130, CON306131, CON306132, CON306268, CON306269, CON306292, CON306293, CON306336, CON306342, CON306435, CON306469, CON311478, CON318487, CON318711, CON318725; GTIN 00888707007658, Serial Numbers: CON413224, CON413247, CON413272, CON413279, CON413281, CON413282, CON413288, CON413289, CON413387, CON413417, CON413419, CON413420, CON413447, CON413448, CON413460, CON413910, CON413939, CON413948, CON415371, CON415373, CON416868, CON416871, CON416872 |
Recalling Firm/ Manufacturer |
Heartware, Inc. 14400 Nw 60th Ave Miami Lakes FL 33014-2807
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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. |
Quantity in Commerce | 59 units |
Distribution | Finland and Turkey |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = DSQ
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