|
Product Description
|
Recall Class
|
FDA Recall Posting Date
|
Recalling Firm
|
Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Ca...
|
2
|
12/22/2008
|
Thoratec Corp
|
HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P...
|
2
|
11/24/2009
|
Thoratec Corp
|
HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS...
|
2
|
10/13/2010
|
Thoratec Corp
|
HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief.
The Seal...
|
1
|
03/23/2012
|
Thoratec Corporation
|
HeartMate II System Controller
Product Usage: HeartMate II is a mechanical device that circulate...
|
1
|
03/21/2014
|
Thoratec Corporation
|
HeartMate II Implant Kit with Pocket Controller;
with sealed grafts (NAm)
with sealed grafts (EU)
...
|
1
|
03/21/2014
|
Thoratec Corporation
|
HeartMate II LVAD Pump and Pock Controller Kit;
Product Usage: HeartMate II is a mechanical de...
|
1
|
03/21/2014
|
Thoratec Corporation
|
Heart Mate II Pocket Controllers removed from packaging
Product Usage: HeartMate II is a mecha...
|
1
|
03/21/2014
|
Thoratec Corporation
|
HeartMate® II LVAS with Pocket Controller;
107801 - HMII PUMP & POCKET CTRL ONLY
UDI:008130240112...
|
1
|
05/24/2017
|
Thoratec Corporation
|
HeartMate® II LVAS with Pocket Controller;
106015 - HMII LVAD SEALED KIT-PCTRL, NA
UDI: 008130240...
|
1
|
05/24/2017
|
Thoratec Corporation
|