FDA recall Z-0475-2024

Product

HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

Reason for recall

Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

Distribution

Worldwide

Key facts

Status

Ongoing

Initiation date

2023-10-31

Report date

2023-12-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0475-2024