Events

Recall of Device Recall FastCath" Transseptal Guiding Introducer

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by St Jude Medical 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
    63855
  • Event Risk Class
    Class 3
  • Event Number
    Z-0617-2013
  • Event Initiated Date
    2012-03-28
  • Event Date Posted
    2012-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114913
  • 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 is recalling a single batch of fast cath transseptal guiding introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.
  • Action
    St Jude Medical hand delivered the" Product Recall" letter dated March 27, 2012, to the affected customers on April 5, 2012, and March 28, 2012. The letter identified the product, the problem and the action needed to be taken by the customer. The returned devices and those not distributed were quarantined at the SJM Minnetonka distribution center until their destruction. Customers were requested to to complete and return the reconciliation form. Further questions please call (651) 756-6526

Device

Device Recall FastCath" Transseptal Guiding Introducer
  • Model / Serial
    Model no. 406586 Batch no. 3619533
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution only including the states of FL, KY and OK.
  • Product Description
    Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 || Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
  • Manufacturer
    St Jude Medical Inc

Manufacturer

St Jude Medical Inc
  • Manufacturer Address
    St Jude Medical Inc, 177 E County Road B, Saint Paul MN 55117-1951
  • 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