Atlas FDA

Thoratec Corporation

8 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch Thoratec Corporation

RecordFirmDate
HeartMate II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:008130 recall (Z-2051-2017)Thoratec Corporation2017-05-24
HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 008 recall (Z-2052-2017)Thoratec Corporation2017-05-24
HeartMate II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 008130 recall (Z-2053-2017)Thoratec Corporation2017-05-24
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed graf recall (Z-1227-2014)Thoratec Corporation2014-03-21
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that cir recall (Z-1228-2014)Thoratec Corporation2014-03-21
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a m recall (Z-1230-2014)Thoratec Corporation2014-03-21
HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanica recall (Z-229-2014)Thoratec Corporation2014-03-21
HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. recall (Z-1228-2012)Thoratec Corporation2012-03-23

Track Thoratec Corporation automatically

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