Events

Recall of Telesheath Catheter TwoPiece Introducer Kit with Hemostasis Valve

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
    29848
  • Event Risk Class
    Class 2
  • Event Number
    Z-1426-04
  • Event Initiated Date
    2004-08-04
  • Event Date Posted
    2004-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34648
  • 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
    St. jude medical received two complaints from customers involving the telesheath left atrial introducer system side arm detaching from the hub of the inner sheath. subsequent testing of telesheath inventory at st. jude medical indicated that the side arm from the inner sheath can detach during routine handling and manipulation, and occurs on a random basis.
  • Action
    100% of customers were notified by a personal visit by a St. Jude Medical representative, starting 8/4/2004. Letters were given by the representative to the consignee concerning the recall.

Device

Telesheath Catheter TwoPiece Introducer Kit with Hemostasis Valve
  • Model / Serial
    1063074 - Exp Date: 03/2007, 1075104, - Exp. Date: 05/2007, 1076753 - Exp. Date: 06/2007
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US, Canada, Belgium, Hong Kong, and Japan.
  • Product Description
    Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Left Lateral Reorder #407901. The product is packaged in an open, semi-rigid plastic tray, which is then placed in a sterile barrier pouch consisting of Tyvek on one side and a clear plastic film on the other. This pouch is then heat sealed prior to sterilization.
  • 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