Home / Recalls / Thoratec Corporation / Z-2051-2017

Z-2051-2017 Class I Terminated

Recalled by Thoratec Corporation — Pleasanton, CA

FDA device recall Z-2051-2017 was initiated by Thoratec Corporation on March 30, 2017 and is designated Class I. 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 … The recall status is terminated (terminated March 20, 2019). Affected quantity: 24,077 active units in US.

Recall Details

Product Type: Devices
Report Date: May 31, 2017
Initiation Date: March 30, 2017
Termination Date: March 20, 2019
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24,077 active units in US

Product Description

HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY 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.

Distribution Pattern

Worldwide Distribution -- US and Austria, Belgium, Brazil, Canada, Cayman Islands, Chile, Columbia, Croatia, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Kazakhstan, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Malaysia, Orman, Palastine, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, The Netherlands, Turkey, United Arab Emirates, and United Kingdom.

Code Information

All Serial numbers.

Other recalls by Thoratec Corporation

Z-2053-2017 Class I — HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA (March 30, 2017)
Z-2052-2017 Class I — HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL (March 30, 2017)
Z-1230-2014 Class I — Heart Mate II Pocket Controllers removed from packaging Product Usage: Hea (March 4, 2014)
Z-1227-2014 Class I — HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with (March 4, 2014)
Z-1228-2014 Class I — HeartMate II System Controller Product Usage: HeartMate II is a mechanical d (March 4, 2014)
Z-229-2014 Class I — HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate I (March 4, 2014)