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
- Company
- Thoratec Corp
- Recall Initiated
- August 25, 2006
- Posted
- October 3, 2006
- Terminated
- November 27, 2007
- Recall Number
- Z-0004-2007
- Quantity
- 114 devices (57 valves/2 per unit)
- Firm Location
- Pleasanton, CA
Reason for Recall
Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.
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.)--
Lot / Code Info
All Codes (Valve Disk Lot 20052904)
Root Cause
Other
Action Taken
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'.
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