Heartware, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0480-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN

Product Classification:

Class II

Date Initiated: October 31, 2023

Date Posted: December 13, 2023

Recall Number: Z-0480-2024

Event ID: 93405

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

Status: Ongoing

Product Quantity: 6 units

Code Information:

Serial numbers: HW24101, HW24102, HW24103, HW24104, HW24763, HW24755FSCA

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated