| Class 2 Device Recall Thoratec Portable Ventricular Assist Driver | |
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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = DSQ
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