Heartware recalls HVAD System Model 1104 due to Finnish and Turkish translation errors in controller displays and instructions, which could lead to miscommunication with 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 Model 1104 because translation errors in the device displays and instructions could cause confusion for patients and emergency responders. This affects patients using the device and those who might need to respond to emergencies involving the device.
The device displays and instructions contain Finnish and Turkish translation errors, which could lead to misunderstandings about device settings or emergency procedures. This might cause confusion during critical situations when patients or responders need to follow instructions.
Patients with Heartware HVAD implants and emergency responders who might interact with the device are affected. Those with the specific model numbers listed in the recall are most at risk.
Check for the model number 1104 on the device, and look for the specific serial numbers listed in the recall notice. The product was sold with GTIN numbers starting with 00888707.
Review the device's manual and display settings for Finnish or Turkish language errors.
Heartware identified translation errors in the device displays and instructions that could cause confusion for patients and emergency responders.
The recall does not require stopping use; it focuses on checking for translation errors in documentation.
Check the device's serial number against the list provided in the recall notice to confirm if it's affected.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1102-2022 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1102-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
