|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
|
2
|
05/17/2022
|
Heartware, Inc.
|
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets:
HVAD® System Emergency Re...
|
2
|
05/17/2022
|
Heartware, Inc.
|
HeartWare Ventricular Assist Device (HVAD) System
|
2
|
03/04/2022
|
Heartware, Inc.
|
Medtronic HVAD Pump Implant Kits
|
2
|
09/16/2021
|
Heartware, Inc.
|
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support i...
|
2
|
07/13/2021
|
Heartware, Inc.
|
Instructions for Use and Patient Manual for HeartWare HVAD System.
Accompanies these devices:
Heartw...
|
2
|
04/21/2021
|
Heartware, Inc.
|
Instructions for Use and Patient Manual for HeartWare HVAD System.
Accompanies these devices:
Hear...
|
2
|
04/20/2021
|
Heartware, Inc.
|
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The...
|
2
|
12/07/2018
|
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 Ventricular Assist System (HVAD)
For use as a bridge-to-cardiac transplantation in patien...
|
2
|
06/26/2015
|
HeartWare Inc
|