Events

Recall of Sensei X Robotic Catheter System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by St Jude Medical Australia Pty Ltd.

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
    RC-2014-RN-01325-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-12-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01325-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    There is a potential for the set-up joint sub-assembly to become loose relative to the operating table. should this issue occur during clinical use, it may potentially result in uncontrolled catheter motion.Uncontrolled catheter motion could result in cardiac tamponade or perforation of the heart.
  • Action
    The Customer is requested to ensure that the RCM is secure and tightly connected to the patient table before starting a procedure and check that all clamps are properly tightened. In addition, ensure that the RCM does not come into contact with other laboratory equipment, as this may produce forces capable of dislodging the RCM. In the event the clamp is found to be loose, customers are advised not use the system and to contact St.Jude Medical immediately. This action has been closed-out on 14/07/2016.

Device

Sensei X Robotic Catheter System

Manufacturer

St Jude Medical Australia Pty Ltd
  • 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
    DHTGA