Z-1105-2022 Class II Ongoing
FDA device recall Z-1105-2022 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. Affected quantity: 59 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- Mar 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59 units
Product Description
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
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 00888707000420, Serial Numbers: CON306040, CON306041, CON306042, CON306044, CON306045, CON306046, CON306047, CON306085, CON306086, CON306087, CON306088, CON306089, CON306090, CON306093, CON306098, CON306120, CON306123, CON306125, CON306127, CON306128, CON306129, CON306130, CON306131, CON306132, CON306268, CON306269, CON306292, CON306293, CON306336, CON306342, CON306435, CON306469, CON311478, CON318487, CON318711, CON318725; GTIN 00888707007658, Serial Numbers: CON413224, CON413247, CON413272, CON413279, CON413281, CON413282, CON413288, CON413289, CON413387, CON413417, CON413419, CON413420, CON413447, CON413448, CON413460, CON413910, CON413939, CON413948, CON415371, CON415373, CON416868, CON416871, CON416872
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1105-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026