|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
|
2
|
12/02/2023
|
Heartware, Inc.
|
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
|
2
|
12/02/2023
|
Heartware, Inc.
|
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
|
2
|
12/02/2023
|
Heartware, Inc.
|
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
|
2
|
12/02/2023
|
Heartware, Inc.
|
Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420
P...
|
2
|
10/03/2018
|
Heartware, Inc.
|
HeartWare HVAD Driveline Extension Cable, REF 100
|
1
|
08/06/2021
|
Heartware, Inc.
|
HeartWare HVAD Driveline Extension Cable, REF 100US
|
1
|
08/06/2021
|
Heartware, Inc.
|
HeartWare HVAD Implant Kit, REF 1104JP
|
1
|
08/06/2021
|
Heartware, Inc.
|
HeartWare HVAD Implant Kit, REF MCS1705PU
|
1
|
08/06/2021
|
Heartware, Inc.
|
HeartWare HVAD Outflow Graft, REF MCS1725OG
|
1
|
08/06/2021
|
Heartware, Inc.
|