Z-0004-2007

Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed...

Name: Z-0004-2007 Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed...
Creator: Thoratec Corp
Published: 2006-08-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-08-25 / Terminated

FDA source

Thoratec Corp began a recall of Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035... on 2006-08-25. The reason FDA records is "Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0004-2007
Status: Terminated
Initiated: 2006-08-25
Posted: 2006-10-03
Terminated: 2007-11-27
Recalling firm: Abbott Medical
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
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.
FDA root cause: 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.)--
Product codes and lots: All Codes (Valve Disk Lot 20052904)

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)