Class 2 Device Recall Thoratec Dual Drive Console

• Date Initiated by Firm: September 24, 2004
• Date Posted: February 10, 2007
• Recall Status: Terminated on April 18, 2008
• Recall Number: Z-0412-2007
• Recall Event ID: 36154
• PMA Number: P870072
• Product Classification: Ventricular Assist Device console - Product Code DSQ
• Product: Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
• Code Information: All Dual Drive Consoles manufactured before July 10, 2002 with serial numbers between 301 and 636, inclusive
• FEI Number: 2916596
• Recalling Firm/ Manufacturer: Thoratec Corp; 6035 Stoneridge Drive; Pleasanton CA 94588
• For Additional Information Contact: Gary D. Cederwall; 925-730-4118
• Manufacturer Reason for Recall: The module power switch (at the back of console) may break while attempting to turn the Dual Drive Console OFF or ON.
• FDA Determined Cause: Other
• Action: The firm issued on 1/25/07 an URGENT: MEDICAL DEVICE CORRECTION-notice informing its consignees about the 'Power Switch Replacement Instructions' and arrangements for their service department replacement of the switches.
• Quantity in Commerce: 331
• Distribution: Worldwide
• 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