Class 1 Device Recall HeartMate II Implant Kit with Pocket Controller;

• Date Initiated by Firm: March 04, 2014
• Date Posted: March 21, 2014
• Recall Status: Terminated on August 27, 2015
• Recall Number: Z-1227-2014
• Recall Event ID: 67639
• PMA Number: P060040
• Product Classification: Ventricular (assisst) bypass - Product Code DSQ
• Product: 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.
• Code Information: Catalog number 106015 (NAm) 106016 - EU all serial numbers
• Recalling Firm/ Manufacturer: Thoratec Corporation; 6035 Stoneridge Dr; Pleasanton CA 94588-3270
• For Additional Information Contact: Donald A. Middlebrook; 925-847-8600
• Manufacturer 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.
• FDA Determined 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 to customer.service@thoratec.com. For questions call 1-800-528-2577.
• Quantity in Commerce: 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, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = DSQ