Events

Recall of Device Recall Cook ATB Advance PTA Dilatation Catheter

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

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
    37568
  • Event Risk Class
    Class 2
  • Event Number
    Z-0665-2007
  • Event Initiated Date
    2007-02-28
  • Event Date Posted
    2007-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50809
  • 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
    angioplasty dilatation catheter - Product Code DQY
  • Reason
    Mislabeled as to size: the outer label reads 7-4.0 balloon, when the balloon is actually 5-2.0.
  • Action
    Consignees were notified via telephone on 2/28/07 and instructed to return the product.

Device

Device Recall Cook ATB Advance PTA Dilatation Catheter
  • Model / Serial
    Lot 1820419.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Illinois, North Carolina and South Carolina.
  • Product Description
    Cook ATB Advance PTA Dilatation Catheter, French size 5, rated burst pressure 15 atm, inflated diameter 7 mm, balloon length 4 cm, recommended introducer French size 6, sterile, REF (Global product no.) G26887, REF (order no.) ATB5-35-40-7-4.0.
  • Manufacturer
    Cook, Inc.

Manufacturer

Cook, Inc.
  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA