Events

Recall of Device Recall Thoratec Portable Ventricular Assist 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
    36186
  • Event Risk Class
    Class 2
  • Event Number
    Z-0004-2007
  • Event Initiated Date
    2006-08-25
  • Event Date Posted
    2006-10-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48148
  • 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
    Portable Ventricular Assist Driver - Product Code DSQ
  • Reason
    Sticky valve disk- the valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.
  • 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'.

Device

Device Recall Thoratec Portable Ventricular Assist Driver
  • Model / Serial
    All Codes (Valve Disk Lot 20052904)
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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 Description
    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
  • Manufacturer
    Thoratec Corp

Manufacturer

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