HeartWare Ventricular Assist Device recalled for translation errors
Heartware, Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) in Finland and Turkey due to translation errors in device displays and supporting documentation that could impair proper device operation.
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 recall affecting a critical life-support device. Although no hospitalizations or injuries have been reported, translation errors in device displays and critical documentation pose a meaningful risk of misuse or improper operation.
Plain-English summary
Heartware, Inc. is recalling specific models of the HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, distributed in Finland and Turkey.
The recall is issued due to translation errors in Finnish and Turkish affecting the controller and monitor displays, as well as the Instructions for Use, Patient Manual, and Emergency Responder Guide. These errors could prevent users from properly understanding device operation and emergency procedures.
The affected serial numbers are MON200197, MON200321, MON200668, and MON200764. Patients or healthcare providers who have devices with these serial numbers should contact their local healthcare provider or Heartware, Inc. to obtain corrected documentation.
The recalled product
- Product
- HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- Manufacturer
- Heartware, Inc.
- Hazard
- translation-error
- mis-labeling
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 (5)
- GTIN 00888707002868
- Serial Numbers: MON200197
- MON200321
- MON200668
- MON200764
Distribution
Distribution scope not specified by the agency.
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