HeartWare HVAD System Controller Recalled for Translation Errors in Documentation
Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall addresses translation errors in device documentation and displays without any reported illnesses or injuries. Per the severity rubric, labeling and documentation errors without reported harm are classified as Moderate (Score 2).
Plain-English summary
HeartWare, Inc. is recalling 667 units of the HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit, distributed in Finland and Turkey. The recall is due to translation errors in Finnish and Turkish language versions of the device controls and documentation.
The translation errors affect the controller and monitor display text, as well as the Instructions for Use, Patient Manual, and Emergency Responder Guide. These errors could lead to patient or caregiver confusion about device operation and status, and could impact the ability of emergency responders to provide appropriate care.
Patients using the HVAD system should contact their healthcare provider to determine if their device is affected based on the provided serial numbers. Healthcare facilities and emergency response personnel in the affected regions should review the recalled product serial numbers to identify affected units.
The recalled product
- Product
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
- Manufacturer
- Heartware, Inc.
- Hazard
- translation-error
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN 00888707001700
- Serial Numbers: CON300826
- CON302649
- CON304346
- CON305438
- CON305669
- CON309302
- CON309306
- CON309974
- CON312894
- CON313111
- CON313129
- CON313154
- CON314788
- CON314789
- CON314903
- CON314929
- CON315066
- CON315120
- CON315384
Distribution
Distribution scope not specified by the agency.
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