Class 1 Device Recall Thoratec TLCII Portable VAD driver

• Date Initiated by Firm: June 08, 2007
• Date Posted: July 27, 2007
• Recall Status: Terminated on July 17, 2008
• Recall Number: Z-1108-2007
• Recall Event ID: 38325
• PMA Number: P870072S012
• Product Classification: Ventricular Assist Device System (VAD) - Product Code DSQ
• Product: Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system
• Code Information: Catalog number 20010-0000-032. All units manufactured or serviced since August, 2005.
• Recalling Firm/ Manufacturer: Thoratec Corp; 6035 Stoneridge Drive; Pleasanton CA 94588
• For Additional Information Contact: 925-847-8600
• Manufacturer Reason for Recall: Component Failure; Device Failure without warning; due to premature wear-out of the compressor motor, VAD support for the patient's circulatory system may fail without warning.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Urgent Medical Device Recall letters, dated June 08, 2007, were issued to consignees, with instructions to take the following actions: 1) check the current number of service hours on all units. 2) do not use TLC-II drivers exceeding 1500 hours until they are serviced by thoratec. 3) note the indicated hours on the product inventory form and return the form to Thoratec. 4) ensure that all patients have a back up driver and hand pumps at all times and have been trained in backup procedures. The firm is also arranging for the return and servicing of all affected drivers, with highest priority to those drivers already exceeding 1500 hours of life. A July 19, 2007, Press Release was issued by the firm.
• Quantity in Commerce: 378 drivers
• Distribution: Worldwide: USA including states of AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NY, OH, OR, PA, TN, TX, UT, VA, and WA, as well as, countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Qatar, Singapore, Switzerland, Taiwan, UAE, and UK.
• 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