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 is recalling certain ventricular assist device monitors because logfiles from updated models can't be processed by the Autologs web portal. This issue affects patients using these devices, as it may prevent proper monitoring and data management.
The logfiles downloaded from the updated monitors (Model 1521) cannot be processed by the Autologs web portal. This means healthcare providers may not be able to access or manage patient data effectively through the portal, potentially impacting monitoring and treatment decisions.
Patients using Heartware ventricular assist device monitors with the specific model numbers and serial numbers listed in the recall are affected. Healthcare providers managing these devices are most at risk of data management issues.
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.
Identify your monitor's model number (1521US, 1521GB, 1521IL, or 1521DE) and serial number to confirm if it's affected.
Reach out to Heartware directly for guidance on next steps if your monitor is listed in the recall.
Heartware has identified that logfiles from recently updated Model 1521 monitors cannot be processed by the Autologs web portal, which may impact patient data management.
No, the recall does not require immediate discontinuation of use. Affected units need to be checked for compatibility with the Autologs portal.
Check your monitor's model number and serial number against the list provided in the recall notice.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1993-2023 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1993-2023 from Heartware. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
