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U.S. Department of Health and Human Services

Class 2 Device Recall Thoratec Portable Ventricular Assist Driver

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 Class 2 Recall
Thoratec Portable Ventricular Assist Driver
see related information
Date Posted October 03, 2006
Recall Status1 Terminated on November 27, 2007
Recall Number Z-0004-2007
Recall Event ID 36186
Premarket Approval
PMA Number
P870072/S012
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Code Information All Codes (Valve Disk Lot 20052904)
Recalling Firm/
Manufacturer
Thoratec Corp
6035 Stoneridge Drive
Pleasanton, California 94588
For Additional Information Contact Gary Cederwall
925-730-4118
Manufacturer Reason
for Recall
Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On 8/26/06, the firm issued letters to all its direct consignees, informing them of the affected product and providing 'IMPORTANT PRODUCT SAFETY BULLETIN'.
Quantity in Commerce 114 devices (57 valves/2 per unit)
Distribution Worldwide distribution-USA including states of AL, CA, CT, FL, IL, IN, KY, LA, MA, ME, MI, MN, NC, NY, OH, PA, TN, TX, VA, WA, and WI., with 19 Foreign consignees Australia, Belgium, Canada*, Czech Republic, France, Germany, Ireland, Netherlands, Portugal, Switzerland, United Kingdom. (*Hospital Royal Victoria, Queen Elizabeth II/Capital Health, St. Paul's Hospital, Vancouver, Canada.)--
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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