Heartware recalls HVAD System Controller Model 1420 due to Finnish and Turkish translation errors in displays and manuals, potentially causing confusion for patients and responders.
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
Heartware is recalling its HVAD System Controller Model 1420 because it has Finnish and Turkish translation errors in displays and documentation. This could lead to misunderstandings for patients and emergency responders using the device.
The controller and related documents have translation errors in Finnish and Turkish, which could cause confusion during critical situations. This might lead to incorrect understanding of device status or emergency procedures.
Patients using the Heartware HVAD System Controller Model 1420 with the listed serial numbers are affected. Those who rely on accurate translations for device operation or emergency response are at higher risk.
Check if your Heartware HVAD System Controller has the Model Number 1420 and one of the listed serial numbers. The product includes specific serial numbers and GTIN identifiers.
Look for the serial number on your controller to see if it matches the list of affected units provided in the recall.
Heartware is recalling the HVAD System Controller Model 1420 due to Finnish and Turkish translation errors in displays and documentation.
Check the serial number on your controller against the list of affected serial numbers provided in the recall notice.
The recall does not require immediate action beyond checking if your device is on the list. Heartware has not provided a specific remedy for this issue.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1104-2022 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1104-2022 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.
