HeartWare Ventricular Assist Device controller has translation errors in Finnish, Turkish
HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall of a life-critical cardiac device. Although no injuries have been reported, translation errors in Instructions for Use and Emergency Responder Guides represent a risk-of-harm situation where improper device operation or emergency response could result from misunderstanding.
Plain-English summary
HeartWare, Inc. is recalling 510 HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 units due to translation errors in Finnish and Turkish languages.
The affected units were distributed in Finland and Turkey. The device's controller and monitor displays, Instructions for Use, Patient Manual, and Emergency Responder Guide contain inaccurate translations in Finnish and Turkish.
Translation errors in these critical documents could affect a patient's ability to properly operate the device or a healthcare provider's ability to respond to device emergencies. This is a Class II recall.
Patients and healthcare providers using affected HVAD controllers should contact HeartWare, Inc. or their healthcare provider to obtain corrected documentation in the appropriate language.
The recalled product
- Product
- HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
- 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 00888707000420
- Serial Numbers: CON301559
- CON301671
- CON301680
- CON301691
- CON301692
- CON301699
- CON301714
- CON301828
- CON302225
- CON302283
- CON302286
- CON302325
- CON303175
- CON303662
- CON303733
- CON303773
- CON304089
- CON304110
- CON304225
Distribution
Distribution scope not specified by the agency.
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