Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HeartWare Ventricular Assist Device (HVAD) System Controller Recalled by Heartware, Inc. Due to Finnish and Turkish translation errors in HVAD controller...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Heartware, Inc. directly.
Affected Products
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Quantity: 667 units
Why Was This 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.
Where Was This Sold?
Finland and Turkey
About Heartware, Inc.
Heartware, Inc. has 60 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report