ProductGuru Recalls

Brand

Heartware, Inc.: official recall notices

5 official recall or safety notices published on this site name Heartware, Inc., dated 2023-10-31. They were issued by 1 authority: US FDA — Medical Devices (5).

Countries where the notices were issued: United States (5).

Name as written in the notices: Heartware, Inc.. This is the brand or the responsible company as each authority recorded it. A recall shows a safety system working; it is not a verdict on a brand. Follow the official notice for each product.

What this page counts: the notices published as pages on product-guru.org, over every date (this site publishes a selection of the notices in the ProductGuru index). The brand scorecards count every indexed notice in a rolling 24-month window instead, so their totals differ from this page.

Notices by year

YearNotices
20235

Notices by authority

AuthorityNotices
US FDA — Medical Devices5

All notices

DateAuthorityProductHazard (as classified)
2023-10-31US FDA — Medical DevicesPUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103—
2023-10-31US FDA — Medical DevicesHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205—
2023-10-31US FDA — Medical DevicesPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP—
2023-10-31US FDA — Medical DevicesHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100—
2023-10-31US FDA — Medical DevicesPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104—

All brands →