Events

Recall of Device Recall Guidant

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

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
    28498
  • Event Risk Class
    Class 2
  • Event Number
    Z-0790-04
  • Event Initiated Date
    2004-03-11
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32062
  • 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
    Cannula, Catheter - Product Code DQR
  • Reason
    The terminal hub component in a some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
  • Action
    Starting on March 11, 2003, the firm''s representatives visited consignees, to whom the recalled catheters had been consigned, and retrieved the catheters.

Device

Device Recall Guidant
  • Model / Serial
    Lots 4012251, 4012451, 4012851, 4012951, 4020451, 4021951, and 4022551
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in the United States.
  • Product Description
    Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, CS Wide Tip Shape, CS-W, REF 6705
  • Manufacturer
    Guidant Corp-Cpi Division

Manufacturer

Guidant Corp-Cpi Division
  • Manufacturer Address
    Guidant Corp-Cpi Division, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA