Events

Recall of FastCath

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St. Jude Medical / Daig 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
    36605
  • Event Risk Class
    Class 2
  • Event Number
    Z-0535-2007
  • Event Initiated Date
    2006-10-05
  • Event Date Posted
    2007-03-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48983
  • 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
    Transseptal Catheter Introducer - Product Code DYB
  • Reason
    Limited number of fastcath transseptal catheter introducers (ref #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
  • Action
    The affected customers were notified on 10/5/06 by letter.

Device

FastCath
  • Model / Serial
    Lot number 1239904
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
  • Manufacturer
    St. Jude Medical / Daig Division

Manufacturer

St. Jude Medical / Daig Division
  • Manufacturer Address
    St. Jude Medical / Daig Division, 14901 Deveau Pl, Minnetonka MN 55345-2126
  • Source
    USFDA