Recall Z-1227-2014 · DSQ Ventricular (Assist) Bypass

Thoratec Corporation

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.

Date	Mar 21, 2014 (initiated Mar 4, 2014)
Status	Terminated
Reason	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.
Root cause	Device Design
Action	Thoratec sent an Urgent Medical Device Correction letter dated March 4, 2014 to all affected customers. The letter was sent via e-mail. All distributors outside of the USA and Canada to whom affected product has been distributed have been notified of this field correction notice and have been provided copies of the Customer Letter to forward to their customers. The letter identified the affected product , problem and actions to be taken. Customers were requested to complete and sign the attached Acknowledgement Form and return it to Thoratec via fax (925-847-8571) or e-mail a scanned copy
Quantity	1737 catalog number 106015; 609 catalog number 106016
Distribution	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, Le
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.