|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (...
|
1
|
07/08/2016
|
Heartware, Inc.
|
HeartWare Ventricular Assist System (HVAD).
Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1...
|
1
|
06/13/2015
|
HeartWare Inc
|
HeartWare Ventricular Assist System (HVAD).
Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, ...
|
1
|
06/11/2015
|
HeartWare Inc
|
HeartWare Ventricular Assist System (HVAD).
Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,11...
|
1
|
06/08/2015
|
HeartWare Inc
|
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit
Product Usage:
Is intended ...
|
1
|
05/14/2015
|
HeartWare Inc
|
HeartWare Ventricular Assist System (HeartWare Controller)
Product Usage:
For use as a bridge-to...
|
1
|
02/25/2015
|
HeartWare Inc
|
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101,...
|
1
|
04/23/2014
|
HeartWare Inc
|
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
|
2
|
12/02/2023
|
Heartware, Inc.
|
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
|
2
|
12/02/2023
|
Heartware, Inc.
|
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
|
2
|
12/02/2023
|
Heartware, Inc.
|