Events

Recall of St. Jude Medical FASTCATH Hemostasis Introducer

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

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
    53121
  • Event Risk Class
    Class 2
  • Event Number
    Z-2229-2009
  • Event Initiated Date
    2009-08-17
  • Event Date Posted
    2009-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84689
  • 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
    Wire, guide, catheter - Product Code DQX
  • Reason
    St. jude medical has initiated a voluntary recall of two lots of fast-cath hemostasis introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. they discovered that the product lots could contain some items which have been mis-labeled with the incorrect french size. in one case, the pouch label does not correctly identify the content of the pouch. in another.
  • Action
    Field Representatives were sent a "St Jude Medical Urgent Product Information" letter to be hand delivered to their customers. The letter listed the products and problem and advised consignees to discontinue use of the product. A form was attached for the return of products to the firm. Contact your local St Jude Medical representative for further information.

Device

St. Jude Medical FASTCATH Hemostasis Introducer
  • Model / Serial
    Lot Number: 4219
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.
  • Product Description
    St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. || Used for the introduction of catheters into a vessel.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Manufacturer Address
    St. Jude Medical, 14901 DeVeau Place, Minnetonka MN 55345
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA