Z-1105-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 25, 2022
- Initiation Date
- March 30, 2022
- Termination Date
- N/A
- 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