FDA recall Z-1102-2022

Product

HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104

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

Finland and Turkey

Key facts

Status

Ongoing

Initiation date

2022-03-30

Report date

2022-05-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1102-2022