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U.S. Department of Health and Human Services

Class 2 Device Recall Heart Ware(TM) HVAD(TM) System

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  Class 2 Device Recall Heart Ware(TM) HVAD(TM) System see related information
Date Initiated by Firm August 28, 2018
Create Date October 03, 2018
Recall Status1 Terminated 3 on April 05, 2019
Recall Number Z-0067-2019
Recall Event ID 80966
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420

Product Usage:
The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Code Information Serial number range: CON300175 - CON320540
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		 Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.
FDA Determined
Cause 2		 Device Design
Action Medtronic began notifying Clinicians in the US on 28-Aug-2018 mainly via 2-day courier, of the identified issues and provided patient management recommendations. Outside the US, Medtronic began notifying Clinicians on 30-Aug-2018 via locally approved methods.
Quantity in Commerce 17,275 units
Distribution Worldwide Distribution
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Medtronic
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