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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 Device Recall Thoratec Portable Ventricular Assist Driver see related information
Date Initiated by Firm August 25, 2006
Date Posted October 03, 2006
Recall Status1 Terminated 3 on November 27, 2007
Recall Number Z-0004-2007
Recall Event ID 36186
PMA Number P870072S012 
Product Classification Portable Ventricular Assist Driver - 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 CA 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		 Other
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 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 and Original Applicant = THORATEC LABORATORIES CORP.
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