Recall of Device Recall COOK Stiffened Micropuncture Introducer Set

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    The tip of the stiffened cannula might break during use and remain in the patient.
  • Action
    Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.


  • Model / Serial
    All lots on the market as of 11/25/2002.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    United States, Brazil, Canada, Dominican Republic and Israel.
  • Product Description
    COOK Stiffened Micropuncture¿ Introducer Set, 5 FR. || Product Reorder Number: MPIS-501-15.0-SC-NT-MKDT-090600
  • Manufacturer


  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, P.O. Box 489, Bloomington IN 47402-0489
  • Source