Thoratec Corporation
Thoratec Corporation appears in FDA public data with 7 recalls — including 7 Class I (most serious) —, 2 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2053-2017, Class I) was initiated on March 30, 2017. Its most recent 510(k) clearance was granted on September 18, 2015.
Summary
- Total Recalls
- 7 (7 Class I)
- 510(k) Clearances
- 2
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2053-2017 | Class I | HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 008130240112 | March 30, 2017 |
| Z-2051-2017 | Class I | HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:008130240112 | March 30, 2017 |
| Z-2052-2017 | Class I | HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 008130240 | March 30, 2017 |
| Z-1230-2014 | Class I | Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mecha | March 4, 2014 |
| Z-1227-2014 | Class I | HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) | March 4, 2014 |
| Z-1228-2014 | Class I | HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulate | March 4, 2014 |
| Z-229-2014 | Class I | HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical de | March 4, 2014 |