Events

Recall of Device Recall Thoratec

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
    25262
  • Event Risk Class
    Class 3
  • Event Number
    Z-0491-03
  • Event Initiated Date
    2002-12-16
  • Event Date Posted
    2003-01-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25493
  • 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) Bypass - Product Code DSQ
  • Reason
    The product is mislabeled, in that the lvad pneumatic lead 5' is identified with a blue collar (instead of red) in order to distinguish rvad.
  • Action
    On 12/16/02, the firm initiated the recall and their notification was via letters requesting return of affected devices.

Device

Device Recall Thoratec
  • Model / Serial
    Lot Number: 17482
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    The unit containing the affected product was shipped to a total of 25 hospitals in IL, PA, NY, TX, WI, FL, IN, WA, OK, AL, and WA-DC. The recall was appropriately extended to the consumer/user level; i.e., the hospitals, which received the recalled product. There is no known U. S. Government accounts but there are 3 foreign accounts: Canada, France and Spain.
  • Product Description
    Thoratec Sterile LVAD Pneumatic Lead 5'' ; || Model/Product Number: 20010-0000-108
  • Manufacturer
    Thoratec Corp

Manufacturer

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