Heartware, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0475-2024)

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:

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

Product Classification:

Class II

Date Initiated: October 31, 2023

Date Posted: December 13, 2023

Recall Number: Z-0475-2024

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: 45 units

Code Information:

Serial numbers: HW001, HW012, HW016, HW017, HW023, HW025, HW028, HW044, HW045, HW046, HW047, HW049, HW050, HW051, HW061, HW064, HW083, HW084, HW086, HW091, HW094, HW104, HW105, HW108, HW109, HW110, HW114, HW115, HW116, HW119, HW126, HW127, HW129, HW130, HW131, HW138, HW139, HW143, HW146, HW147, HW153, HW156, HW161, HW170, HW181

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated