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Thoratec Corp.

19 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1 recall (Z-1921-2024)Thoratec Corp.2024-06-07
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly recall (Z-1692-2024)Thoratec Corp.2024-05-01
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly recall (Z-1693-2024)Thoratec Corp.2024-05-01
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft w recall (Z-1300-2024)Thoratec Corp.2024-03-22
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft wit recall (Z-1301-2024)Thoratec Corp.2024-03-22
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication Syst recall (Z-0842-2024)Thoratec Corp.2024-02-02
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apica recall (Z-2658-2023)Thoratec Corp.2023-09-29
Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory recall (Z-1203-2019)Thoratec Corp.2019-04-19
HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device Sy recall (Z-0058-2011)Thoratec Corp2010-10-13
HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II L recall (Z-0422-2010)Thoratec Corp2009-11-24
Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and recall (Z-0496-2009)Thoratec Corp2008-12-22
Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricu recall (Z-0212-2008)Thoratec Corp2007-11-21
Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular recall (Z-1108-2007)Thoratec Corp2007-07-27
Thoratec Paracorporeal Ventricular Assist Device (PVAD) component of the Thoratec VAD syst recall (Z-1109-2007)Thoratec Corp2007-07-27
Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, M recall (Z-0412-2007)Thoratec Corp2007-02-10
Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device Sy recall (Z-0015-2007)Thoratec Corp2006-10-04
Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2 recall (Z-0004-2007)Thoratec Corp2006-10-03
HeartMate Stroke Volume Limiter (SVL) Catalog # 1295 recall (Z-0688-03)Thoratec Corp2003-03-27
Thoratec Sterile LVAD Pneumatic Lead 5'' ; Model/Product Number: 20010-0000-108 recall (Z-0491-03)Thoratec Corp2003-01-30

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Every clearance here is in the API, with alerts when new ones post.