Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufa
FDA device recall Z-0004-2007 · posted 2006-10-03 · Terminated
Recall details
- Recalling firm
- Thoratec Corp
- Reason for recall
- Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.
- 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'.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSQ
- Quantity affected
- 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 Re
- Date initiated
- 2006-08-25
- Date posted
- 2006-10-03
- Date terminated
- 2007-11-27
- Location
- Pleasanton, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.