Recall Z-2053-2017— Thoratec Corporation
Class I · Terminated
Class I FDA medical device recall by Thoratec Corporation, initiated 2017-03-30, terminated 2019-03-20. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.. Reason: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014..
- Recalling firm
- Thoratec Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-03-30
- Terminated
- 2019-03-20
- Firm location
- Pleasanton, CA, United States
Product description
HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
Reason for recall
St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
Data sourced from openFDA. This site is unofficial and independent of the FDA.