Thoratec Corp
Pleasanton, CA
This page shows every FDA and USDA recall linked to Thoratec Corp. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
23
Total Recalls
2002
First Recall
2024
Most Recent
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386,...
Jun 7, 2024
· Device
Open, Classified
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
May 1, 2024
· Device
Open, Classified
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
May 1, 2024
· Device
Open, Classified
HeartMate 3 Left Ventricular Assist System (LVAS):
1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Inve...
Mar 22, 2024
· Device
Open, Classified
HeartMate II Left Ventricular Assist System (LVAS):
1. HeartMate II Sealed Outflow Graft with Bend Relief REF...
Mar 22, 2024
· Device
Open, Classified
1. HeartMate Touch Communication System, REF HMT1100
2. HeartMate Touch Communication System, Rental REF HMT11...
Feb 2, 2024
· Device
Open, Classified
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF:...
Sep 29, 2023
· Device
Open, Classified
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Oct 22, 2021
· Device
Open, Classified
HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 0081302401089...
Dec 2, 2019
· Device
Terminated
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartM...
Apr 19, 2019
· Device
Terminated
Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Mar 30, 2019
· Device
Terminated
Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Lef...
Mar 30, 2019
· Device
Terminated
HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS), distrib...
Oct 13, 2010
· Device
Terminated
HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) an...
Nov 24, 2009
· Device
Terminated
Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Catalog Numb...
Dec 22, 2008
· Device
Terminated
Thoratec Implantable Ventricular Assist Device (IVAD pump)
(Component of Thoratec Ventricular Assist Device (V...
Nov 21, 2007
· Device
Terminated
Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device syste...
Jul 27, 2007
· Device
Terminated
Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD system. Catalog number...
Jul 27, 2007
· Device
Terminated
Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-...
Feb 10, 2007
· Device
Terminated
Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System,
Model Number...
Oct 4, 2006
· Device
Terminated
Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000
Distribut...
Oct 3, 2006
· Device
Terminated
HeartMate Stroke Volume Limiter (SVL)
Catalog # 1295
Mar 27, 2003
· Device
Terminated
Thoratec Sterile LVAD Pneumatic Lead 5'' ;
Model/Product Number: 20010-0000-108
Jan 30, 2003
· Device
Terminated