Events

Recall of Thoratec Dual Drive Console

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
    36154
  • Event Risk Class
    Class 2
  • Event Number
    Z-0412-2007
  • Event Date Posted
    2007-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48091
  • 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 console - Product Code DSQ
  • Reason
    The module power switch (at the back of console) may break while attempting to turn the dual drive console off or on.
  • Action
    The firm issued on 1/25/07 an URGENT: MEDICAL DEVICE CORRECTION-notice informing its consignees about the 'Power Switch Replacement Instructions' and arrangements for their service department replacement of the switches.

Device

Thoratec Dual Drive Console
  • Model / Serial
    All Dual Drive Consoles manufactured before July 10, 2002 with serial numbers between 301 and 636, inclusive
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide
  • Product Description
    Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, 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