FDA Device Recalls

Recalls / Firms / Thoratec Corporation

Thoratec Corporation

8 FDA device recalls on record.

DateClassProductReason
2017-03-30—HeartMate II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286
2017-03-30—HeartMate II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:00813024011286
2017-03-30—HeartMate II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 008130240112
2014-03-04—HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates
2014-03-04—HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) P
2014-03-04—HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical devic
2014-03-04—Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanic
2012-02-23—HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. The Seale