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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) Systemsee related information
Date Initiated by FirmMarch 30, 2022
Create DateMay 17, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1107-2022
Recall Event ID 90079
PMA NumberP100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
ProductHeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Instructions For Use (FI) HVAD System Instructions For Use (FI) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Patient Manual (FI-Finnish) HVAD System Instructions For Use - FI HVAD System Instructions For Use (FI) HVAD System OUS Patient Manual (FI-Finnish) HVAD System Emergency Responder Guide (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System Patient Manual (TR-Turkish) HVAD System OUS Instructions For Use (TR-Turkish)
Code Information No GTIN HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776  HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776  HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R020776  HVAD System Emergency Responder Guide (FI-Finnish), Lot Number: R025893  HVAD System Instructions For Use (FI), Lot Number: R020771  HVAD System Instructions For Use (FI), Lot Number: R020771  HVAD System Patient Manual (FI-Finnish), Lot Number: R020769  HVAD System Patient Manual (FI-Finnish), Lot Number: R020769  HVAD System Patient Manual (FI-Finnish), Lot Number: R020769  HVAD System Patient Manual (FI-Finnish), Lot Number: R020769  HVAD System Patient Manual (FI-Finnish), Lot Number: R020769  HVAD System Patient Manual (FI-Finnish), Lot Number: R020769  HVAD System Patient Manual (FI-Finnish), Lot Number: R021391  HVAD System Patient Manual (FI-Finnish), Lot Number: R021391  HVAD System Patient Manual (FI-Finnish), Lot Number: R022265  HVAD System Instructions For Use - FI, Lot Number: R025606  HVAD System Instructions For Use (FI), Lot Number: R028504  HVAD System OUS Patient Manual (FI-Finnish), Lot Number: R028100  HVAD System Emergency Responder Guide (TR-Turkish), Lot Number: R025877  HVAD System Patient Manual (TR-Turkish), Lot Number: R021248  HVAD System Patient Manual (TR-Turkish), Lot Number: R021248  HVAD System Patient Manual (TR-Turkish), Lot Number: R027179  HVAD System Patient Manual (TR-Turkish), Lot Number: R027179  HVAD System OUS Instructions For Use (TR-Turkish), Lot Number: R025760R01   
Recalling Firm/
Manufacturer		 Heartware, Inc.
14400 Nw 60th Ave
Miami Lakes FL 33014-2807
For Additional Information ContactMCS 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
ActionStarting 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 Commerce645 units
DistributionFinland and Turkey
Total Product Life CycleTPLC 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 DatabasePMAs with Product Code = DSQ
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