Events

Recall of Device Recall Thoratec TLCII Portable VAD driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Thoratec Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    38325
  • Event Risk Class
    Class 1
  • Event Number
    Z-1108-2007
  • Event Initiated Date
    2007-06-08
  • Event Date Posted
    2007-07-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53406
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventricular Assist Device System (VAD) - Product Code DSQ
  • Reason
    Component failure; device failure without warning; due to premature wear-out of the compressor motor, vad support for the patient's circulatory system may fail without warning.
  • Action
    Urgent Medical Device Recall letters, dated June 08, 2007, were issued to consignees, with instructions to take the following actions: 1) check the current number of service hours on all units. 2) do not use TLC-II drivers exceeding 1500 hours until they are serviced by thoratec. 3) note the indicated hours on the product inventory form and return the form to Thoratec. 4) ensure that all patients have a back up driver and hand pumps at all times and have been trained in backup procedures. The firm is also arranging for the return and servicing of all affected drivers, with highest priority to those drivers already exceeding 1500 hours of life. A July 19, 2007, Press Release was issued by the firm.

Device

Device Recall Thoratec TLCII Portable VAD driver
  • Model / Serial
    Catalog number 20010-0000-032. All units manufactured or serviced since August, 2005.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide: USA including states of AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NY, OH, OR, PA, TN, TX, UT, VA, and WA, as well as, countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Qatar, Singapore, Switzerland, Taiwan, UAE, and UK.
  • Product Description
    Thoratec TLC-II Portable VAD Driver. Component (pneumatic) driver of Thoratec Ventricular Assist Device system
  • Manufacturer
    Thoratec Corp

Manufacturer

Thoratec Corp
  • Manufacturer Address
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588
  • Source
    USFDA