Heartware recalls HVAD System Model 1521DE due to Finnish and Turkish translation errors in controller displays and instructions, which could cause misunderstandings in critical medical situations.
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 Model 1521DE because translation errors in the device displays and instructions could lead to misunderstandings during critical medical situations. This affects patients using the device and healthcare providers who rely on accurate information.
The device displays and instructions contain Finnish and Turkish translation errors, which could lead to incorrect interpretations of critical medical information. This might cause confusion during emergencies when precise instructions are needed for patient safety.
Patients using the Heartware HVAD System Model 1521DE and healthcare providers who interact with the device are most at risk due to potential misunderstandings from translation errors.
Check for the model number 1521DE on the device or monitor. The specific serial numbers MON200197, MON200321, MON200668, and MON200764 are also affected.
Verify the model number on the device or monitor to confirm if it is 1521DE.
Heartware is recalling the HVAD System Model 1521DE due to Finnish and Turkish translation errors in the device displays and instructions, which could cause misunderstandings in critical medical situations.
The recall record does not specify a remedy, so there is no action required beyond checking if your device matches the model and serial numbers listed.
The recall indicates translation errors could lead to misunderstandings, but the hazard level is low risk as no immediate physical danger is described.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1106-2022 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1106-2022 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.
