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
    36138
  • Event Risk Class
    Class 2
  • Event Number
    Z-0015-2007
  • Event Initiated Date
    2004-01-26
  • Event Date Posted
    2006-10-04
  • 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=48062
  • 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
    arterial cannula - Product Code DSQ
  • Reason
    During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
  • Action
    On 1/26/2004, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

Device

Device Recall Thoratec
  • Model / Serial
    Serial Numbers: 104, 106
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide to 11(eleven) hospitals. The product was shipped within the United States in IL, MA, NC, MD, MO, FL, CA, AZ, PA, and NY. The product was distributed to one consignee in Australia.
  • Product Description
    Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, || Model Number(s): Catalogue numbers: || #100118-- Short, 14mm graft; || #100121-- Long, 14mm graft; || #100129-- Long, 18mm graft. || 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 94588-3270
  • Source
    USFDA