Thoratec Corporation: Medical Device Recall in 2014 - (Recall #: Z-1227-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: March 4, 2014

Date Posted: April 2, 2014

Recall Number: Z-1227-2014

Event ID: 67639

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.

Status: Terminated

Product Quantity: 1737 catalog number 106015; 609 catalog number 106016

Code Information:

Catalog number 106015 (NAm) 106016 - EU all serial numbers

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.

Voluntary or Mandated:

Voluntary: Firm initiated