FDA Medical Device Recalls (openFDA)
Heartware, Inc.: 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
- Recall number
- Z-1993-2023
- Recalling firm
- Heartware, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2023-05-16
- Posted
- 2023-06-22
- Terminated
- not on file
- Reason
- 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.
- Root cause
- 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
- 19 units
- Distribution
- Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P100047"]
- Product code
- DSQ
- Firm FEI
- 3007042319
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28