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HeartWare Ventricular Assist Device System recallZ-1993-2023 · Heartware, Inc. · initiated May 16, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Heartware, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Software change control

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-1993-2023
Status
Open, Classified
Initiated by the company
May 16, 2023
Posted by the FDA
Jun 22, 2023
Recalling firm
Heartware, Inc.
Quantity
19 units
Product code
DSQ
FDA submissions
P100047
Distribution
Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.

Product description

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 (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

32 devices cleared under P100047 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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