Heartware recalls HVAD System Controller Model 1407DE Kit due to Finnish and Turkish translation errors in displays and documentation. Affected units have specific serial numbers and GTINs.
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 1407DE Kit because Finnish and Turkish translations in the device displays and manuals contain errors. This could lead to misunderstandings about device operation or emergency procedures for patients using the heart assist system.
The device displays and manuals contain translation errors in Finnish and Turkish. These errors could cause confusion about device settings or emergency procedures, but the device itself does not malfunction or pose a physical hazard.
Patients using the Heartware HVAD System Controller Model 1407DE Kit with specific serial numbers and GTINs are affected. Healthcare providers and patients with the device are most at risk due to potential translation errors in critical documentation.
Check if your HVAD System Controller has serial numbers listed in the provided list (e.g., CON300826, CON315106) or GTINs 00888707001700, 00888707002813, or 00888707006941.
Compare your device's serial number with the list of affected serial numbers provided in the recall notice.
Heartware is recalling the HVAD System Controller Model 1407DE Kit due to Finnish and Turkish translation errors in the device displays and manuals.
The recall record states there are translation errors in Finnish and Turkish, but does not specify the exact errors.
The recall does not require immediate action, but you should check if your device is affected by comparing serial numbers with the provided list.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1103-2022 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1103-2022 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.
