HeartWare Ventricular Assist Device recall
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Why was HeartWare Ventricular Assist Device recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764
- Product
- HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
- Recalling firm
- Heartware, Inc.
- Quantity
- N/A
- Distribution
- Finland and Turkey
- Recall date
- May 25, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)