Events

Recall of Device Recall Guidant ENDOTAK SQ Array

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

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
    32395
  • Event Risk Class
    Class 2
  • Event Number
    Z-1441-05
  • Event Initiated Date
    2005-06-13
  • Event Date Posted
    2005-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39964
  • 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
    Introducer, Catheter - Product Code DYB
  • Reason
    A manufacturer for guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.
  • Action
    By Telephone, 6/13/2005. Guidant Sales Reps are to visit hospitals to remove any remaining inventory. Dear Hospital Administrator letter may be left with hospital to explain the removal of product.

Device

Device Recall Guidant ENDOTAK SQ Array
  • Model / Serial
    model 0048, serial numbers 200652 and 200655.  model 0049, serial numbers 202864 thru 202900. model 0085, serial numbers 102087 thru 103287.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    nationwide and worldwide.
  • Product Description
    Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/Defibrillation Lead. Guidant Corporation Cardiac Rhythm Management 4100 Hamline Avenue North, St. Paul, MN 55112-5798. Sterilized with gaseous ethylene oxide.
  • Manufacturer
    Guidant Corporation

Manufacturer

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