Heartware recalls HVAD ventricular assist device system pamphlets with Finnish and Turkish translation errors in instructions and patient guides. Affected units include specific lot numbers and language versions.
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 certain Finnish and Turkish language versions of its HVAD ventricular assist device system pamphlets due to translation errors. These errors could lead to misunderstandings about device use, potentially affecting patient safety.
Translation errors in the Finnish and Turkish language versions of the HVAD system's instructions, patient manuals, and emergency responder guides could cause confusion about device operation. This might lead to incorrect use or misunderstandings during critical situations.
Patients using the Heartware HVAD system with Finnish or Turkish language pamphlets are most at risk. Healthcare providers and emergency responders who use these materials may also be affected.
Check for Finnish (FI) or Turkish (TR) language versions of the HVAD system pamphlets. Look for specific lot numbers listed in the recall notice, such as R020776, R020771, R020769, etc.
Look for Finnish (FI) or Turkish (TR) language versions of the HVAD system pamphlets, including patient manuals, instructions for use, and emergency responder guides.
Heartware is recalling Finnish and Turkish language versions of its HVAD system pamphlets due to translation errors that could cause confusion about device use.
The affected items are Finnish and Turkish language versions of the HVAD system patient manuals, instructions for use, and emergency responder guides with specific lot numbers listed in the recall notice.
If you have the affected language versions of the pamphlets, check for the specific lot numbers mentioned in the recall notice. No action is needed for the device itself, only the pamphlets.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1107-2022 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1107-2022 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.
