Heartware recalls HVAD System Controller Model 1420-Controller 2.0 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 1420-Controller 2.0 because it has translation errors in Finnish and Turkish language displays and documentation. This could cause confusion for users who rely on these translations for proper device operation.
The controller and monitor displays, as well as the Instructions for Use, Patient Manual, and Emergency Responder Guide, contain translation errors in Finnish and Turkish. This could lead to misunderstandings about device settings or emergency procedures for users who need these translations.
Patients using the Heartware HVAD system with the specific controller model and serial numbers listed are most at risk. Healthcare providers who use the device may also be affected if they rely on the translations.
Check if your Heartware HVAD System Controller has the model number 1420-Controller 2.0 and the specific serial numbers listed in the recall notice. The GTIN numbers 00888707000420 and 00888707007658 are also associated with affected units.
Look for the serial numbers listed in the recall notice to determine if your controller is affected.
Heartware is recalling the HVAD System Controller Model 1420-Controller 2.0 due to translation errors in Finnish and Turkish language displays and documentation.
The recall does not specify a remedy, so you should check the serial numbers against the list provided to see if your unit is affected.
The recall states there are translation errors, but it does not describe specific safety risks or hazards that could cause injury.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-1105-2022 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-1105-2022 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.
