Home / Recalls / Thoratec Corporation / Z-1227-2014

Z-1227-2014 Class I Terminated

Recalled by Thoratec Corporation — Pleasanton, CA

FDA device recall Z-1227-2014 was initiated by Thoratec Corporation on March 4, 2014 and is designated Class I. Reason for recall: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller mode… The recall status is terminated (terminated August 27, 2015). Affected quantity: 1737 catalog number 106015; 609 catalog number 106016.

Recall Details

Product Type: Devices
Report Date: April 2, 2014
Initiation Date: March 4, 2014
Termination Date: August 27, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1737 catalog number 106015; 609 catalog number 106016

Product Description

HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.

Reason for Recall

Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.

Distribution Pattern

Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.

Code Information

Catalog number 106015 (NAm) 106016 - EU 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-2051-2017 Class I — HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ON (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-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)