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U.S. Department of Health and Human Services

Class 1 Device Recall Thoratec TLCII Portable VAD driver

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 Class 1 Recall
Thoratec TLCII Portable VAD driver
see related information
Date Posted July 27, 2007
Recall Status1 Terminated on July 17, 2008
Recall Number Z-1108-2007
Recall Event ID 38325
Premarket Approval
PMA Number
P870072/S012
Product Classification Ventricular (Assisst) Bypass - 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, California 94588
Consumer Instructions Contact the recalling firm for information
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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = DSQ and Applicant = THORATEC LABORATORIES CORP.
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