Recall company profile

Heartware, Inc. Recalls

Overview of recall records associated with Heartware, Inc., including dates, categories and classifications where available.

9recall records
Dec 13, 2023latest record date
Dec 13, 2023earliest record date

Recall history in this database

Classification mix: Class II: 9.

Medical DeviceDec 13, 2023

Heartware PUMP 1103 HVAD recall — FDA Z-0478-2024

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…

Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 13, 2023

Heartware HVAD recall — FDA Z-0482-2024

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…

Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 13, 2023

Heartware PUMP 1104 HVAD recall — FDA Z-0481-2024

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…

Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 13, 2023

Heartware HVAD recall — FDA Z-0475-2024

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…

Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 13, 2023

Heartware PUMP 1104 HVAD recall — FDA Z-0479-2024

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…

Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 13, 2023

Heartware PUMP MCS1705PU HVAD recall — FDA Z-0483-2024

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…

Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 13, 2023

Heartware STERILE HVAD recall — FDA Z-0476-2024

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…

Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 13, 2023

Heartware HVAD recall — FDA Z-0477-2024

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…

Class IIFDA: OngoingHeartware, Inc.
Medical DeviceDec 13, 2023

Heartware 1104CA-CLIN - HVAD recall — FDA Z-0480-2024

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…

Class IIFDA: OngoingHeartware, Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies Heartware, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.