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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 May 16, 2023
Date Posted June 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-1993-2023
Recall Event ID 92350
PMA Number P100047 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Code Information a) Model Number 1521US, GTIN 00888707009256, Serial/Lot Numbers: MON500010, MON500012, MON500016, MON500028, MON500026, MON500005, MON500006, MON500007. b) Model Number 1521GB, GTIN 00888707006521, Serial/Lot Numbers: MON400039, MON400050, MON400051, MON400052, MON400053, MON400054, MON400061. c) Model Number 1521IL, GTIN 00888707010108, Serial/Lot Number: MON400017. d) Model Number 1521DE, GTIN 00888707010085, Serial/Lot Numbers: MON400045, MON400021, MON400013.
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		 Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
FDA Determined
Cause 2		 Software change control
Action Medtronic Mechanical Circulatory Support issued an URGENT MEDICAL DEVICE COMMUNICATION notice to it consignees on 05/16/2023 by email. The notice explained that logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal. Medtronic is working on an update to the Autologs web portal to resolve the issue. Until the update is complete, logfiles can be sent to dl.mcsclinicalengineering@medtronic.com for report generation. Please note in the email that you have received a logfile upload error and are requesting a logfile report. On about 09/20/2023, a formal Urgent Medical Device Communication notification was sent to Healthcare Professionals (HCPs) informing them of the resolution of the autologs web portal issue previously communicated. Consignees are asked to confirm receipt of the letter and that they have acknowledged the actions to be taken.
Quantity in Commerce 19 units
Distribution Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
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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