Z-1106-2022 Class II Ongoing
FDA device recall Z-1106-2022 was initiated by Heartware, Inc. on Mar 30, 2022 and is designated Class II. Reason for recall: 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… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- Mar 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Reason for Recall
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.
Distribution Pattern
Finland and Turkey
Code Information
GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1106-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026