Lower riskMedical device recall · FDA · Published May 16, 2023
Heartware Ventricular Assist Device Monitors: Logfiles Not Processable by Autologs Portal
Heartware recalls specific models of ventricular assist device monitors due to logfiles from updated units not being compatible with Autologs web portal. Affected units include 1521US, 1521GB, 1521IL, and 1521DE Explore Tech monitors with listed serial numbers.
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.
“Heartware Ventricular Assist Device Monitors: Logfiles Not Processable by Autologs Portal.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58247-heartware-ventricular-assist-device-monitors-logfiles-not-processable-by-autologs. Based on FDA recall #Z-1993-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1993-2023%22&limit=1).
The FDA announced on May 16, 2023, that Heartware, Inc. is recalling the HeartWare Ventricular Assist Device System monitors due to data processing issues. The hazard involves logfiles from updated Model 1521 monitors being unable to be processed by the Autologs web portal.
How to tell if you have it
HeartWare Ventricular Assist Device System
Monitor 1521US Explore Tech, Model Number 1521US, GTIN 00888707009256, Serial Numbers: MON500010, MON500012, MON500016, MON500028, MON500026, MON500005, MON500006, MON500007
Monitor 1521GB Explore Tech, Model Number 1521GB, GTIN 00888707006521, Serial Numbers: MON400039, MON400050, MON400051, MON400052, MON400053, MON400054, MON400061
Monitor 1521IL Explore Tech, Model Number 1521IL, GTIN 00888707010108, Serial Number: MON400017
Monitor 1521DE Explore Tech, Model Number 1521DE, GTIN 00888707010085, Serial Numbers: MON400045, MON400021, MON400013
The hazard
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors are unable to be processed by the Autologs web portal. The affected serial numbers include MON4xxxxxx for OUS and MON5xxxxxx for US.
Context
GovInfoNow's records show Heartware, Inc. has 17 other recalls on record since August 28, 2018. Other recent recalls of similar products include Heartware PUMP 1104 HVAD Implant Kit Recall (October 31, 2023), Heartware Model 1101 Recall (November 29, 2022), and Heartware HVAD System Batteries (June 28, 2022). Boston Scientific issued a recall for its LUX-Dx Cardiac Monitor System on August 6, 2026.
How to tell if you have this one
Check if your monitor has a model number starting with 1521US, 1521GB, 1521IL, or 1521DE followed by 'Explore Tech'. Look for serial numbers listed in the recall: MON4xxxxxx for OUS models and MON5xxxxxx for US models.
Brand
Heartware
Product
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Monitor Model
Identify your monitor's model number (1521US, 1521GB, 1521IL, or 1521DE) and serial number to confirm if it's affected.
Contact Heartware
Reach out to Heartware directly for guidance on next steps if your monitor is listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Missouri, Texas, Virginia.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1993-2023 (May 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1993-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.