Device recall

Z-0004-2007: Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog…

FDA device recall · Class II · Thoratec Corp

Key facts

Recall number (Z-number) Z-0004-2007
Recall event 36186
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
Recalling firm Thoratec Corp
Recall class Class II
Status Terminated
Termination date Nov 27, 2007
PMA numbers P870072, P870072S012
FEI number 2916596

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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