Heartware, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1105-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0

Product Classification:

Class II

Date Initiated: March 30, 2022

Date Posted: May 25, 2022

Recall Number: Z-1105-2022

Event ID: 90079

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.

Status: Ongoing

Product Quantity: 59 units

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

Distribution Pattern:

Finland and Turkey

Voluntary or Mandated:

Voluntary: Firm initiated